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MedWatch Alerts

Click the link below to view current and archived recalls and warnings for both medicines and medical devices of all types. Warnings that apply specifically to ESRD can be found there or in the summaries below. Note: these summaries will remain posted for 6 months before being removed.

http://www.fda.gov/Safety/MedWatch/default.html

Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Increased Risk of Leg and Foot Amputations (5/17/2017)

ISSUE: Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.

Final results from two clinical trials – the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) – showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment. Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs. See the FDA Drug Safety Communication for additional information, including a data summary.

BACKGROUND: This information is an update to the May 18, 2016 MedWatch safety alert. Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through the urine. It is available as a single-ingredient product under the brand name Invokana and also in combination with the diabetes medicine metformin under the brand name Invokamet.

RECOMMENDATION: Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. Talk to your health care professional if you have questions or concerns. Do not stop taking your diabetes medicine without first talking to your health care professional.
Health care professionals should, before starting canagliflozin, consider factors that may predispose patients to the need for amputations. These factors include a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Monitor patients receiving canagliflozin for the signs and symptoms described above and discontinue canagliflozin if these complications occur.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm558605.htm

Phillips Healthcare recalls HeartStart MRx Monitor/Defibrillator due to electrical issues that may prevent the device from operating properly (3/31/2017)

Recalled Product:

  • HeartStart MRx Monitor/Defibrillator
  • Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
  • Manufacturing dates: February 11, 2004 to November 4, 2016
  • Distribution dates: February 12, 2004 to November 4, 2016
  • Devices Recalled in the U.S.: 47,362 units nationwide

Device Use

The HeartStart MRx Monitor/Defibrillator is used to pace people with a slow heart beat or to deliver lifesaving electrical shocks to people with sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating. Electrodes are attached to the patient and then connected to the device to help it analyze a patient's heart rhythm. The electrodes deliver an electrical shock to restore a normal heart rhythm during sudden cardiac arrest, or to pace the heart at a normal rate when it slows down. The HeartStart MRx Monitor/Defibrillator is intended for use by medical professionals who are trained in CPR.

Reason for Recall
Phillips is recalling the HeartStart MRx Monitor/Defibrillator due to electrical and battery connection issues that may prevent the device from powering up, charging, and delivering an electrical shock therapy. The device may also unexpectedly stop pacing. A delay in delivering therapy could result in serious patient injury such as permanent organ damage, brain injury, or death.

Who May be Affected

  • Health care providers and first responders using this defibrillator
  • Patients who may need defibrillation or pacing to restore normal heart rhythm

What to Do
On February, 2017, Phillips Healthcare sent an “Urgent Medical Device Correction” notice to its customers. The cause of the issue can be easily verified by:

  • Identifying affected devices in their possession using the model number information;
  • Inspecting that the battery connector pins are clean, fully extended, and free of residue;
  • Following the rest of the instructions enclosed in the notice, including:
  • Reviewing the information with other staff trained in the use of the defibrillator;
  • Filling out and return the ‘Confirmation Response’ included with the notice; and
  • Contacting Phillips Healthcare for further information or support at 1-800-722-9377.

Contact Information
Health care professionals and consumers with questions related to this recall can contact Phillips Healthcare at 1-800-722-9377.

Date Recall Initiated
February 24, 2017

How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.

Chlorhexidine Gluconate: Drug Safety Communication – Rare but Serious Allergic Reactions (2/2/2017)

ISSUE: FDA is warning that rare but serious allergic reactions have been reported with the widely used skin antiseptic products containing chlorhexidine gluconate. Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years. See the FDA Drug Safety Communication for a data summary.

As a result, FDA is requesting the manufacturers of over-the-counter (OTC) antiseptic products containing chlorhexidine gluconate to add a warning about this risk to the Drug Facts labels.

BACKGROUND: Chlorhexidine gluconate is mainly available in OTC products to clean and prepare the skin before surgery and before injections in order to help reduce bacteria that potentially can cause skin infections. These products are available as solutions, washes, sponges, and swabs and under many different brand names and as generics. Chlorhexidine gluconate is also available as a prescription mouthwash to treat gingivitis and as a prescription oral chip to treat periodontal disease.

Prescription chlorhexidine gluconate mouthwashes and oral chips used for gum disease already contain a warning about the possibility of serious allergic reactions in their labels.

In 1998, FDA issued a Public Health Notice to warn health care professionals about the risk of serious allergic reactions with medical devices such as dressings and intravenous lines that contain chlorhexidine gluconate.

RECOMMENDATION: Health care professionals should always ask patients if they have ever had an allergic reaction to any antiseptic before recommending or prescribing a chlorhexidine gluconate product. Advise patients to seek immediate medical attention if they experience any symptoms of an allergic reaction when using the products. Consider using alternative antiseptics such as povidone-iodine, alcohols, benzalkonium chloride, benzethonium chloride, or parachlorometaxylenol (PCMX) when any previous allergy to chlorhexidine gluconate is documented or suspected.

Patients and consumers should stop using the product that contains chlorhexidine gluconate and seek medical attention immediately or call 911 if they experience symptoms of a serious allergic reaction. These reactions can occur within minutes of exposure. Symptoms include wheezing or difficulty breathing; swelling of the face; hives that can quickly progress to more serious symptoms; severe rash; or shock, which is a life-threatening condition that occurs when the body is not getting enough blood flow.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch alert, including a link to the FDA Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm539575.htm

Tego Connector Recall (2/1/2017)

Tego Connector, Item No. D1000, NM1000

The Tego Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intravascular Administration Set for the administration or withdrawal of fluids to a patient through a cannula or needle placed in the vein or artery. The Tego is a needle-free capping device which closes the end of the catheter. The Tego will permit access to the catheter without the use of needles and therefore passively aid in the reduction of needle stick injuries.

Code Information
3239841, 3239848, 3244021, 3244022, 3244023, 3244558, 3244560, 3246196, 3254636, 3255850, 3258004, 3258326, 3258327, 3260656, 3261516, 3261517, 3265975, 3268523, 3269593, 3269594, 3275467, 3278966, 3278967, 3224799

Recalling Firm/Manufacturer
ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212

For Additional Information Contact
949.366.2183

Manufacturer Reason for Recall
ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices.

FDA Determined Cause
Under investigation by firm

Action
The firm, icumedical, sent an "URGENT: Medical Device Recall Notification" letter dated 8/24/16 to all their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to quarantine any affected devices; remove from use, return to ICU medical, Inc.; and complete and return the recall response form to ICU Medical via fax (801) 264-1755 or at recall@icumed.com (even if you do not have any affected product). Customers with questions are instructed to contact ICU customer service Monday through Friday between 8:30AM and 4:00PM Pacific Time, (866) 829-9025 and select option 8 or email the following: customerservice@icumed.com.

For more information:  www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=149342

Vancomycin Hydrochloride for Injection, USP by Hospira: Recall - Particulate Matter in Vial (1/27/2017)

ISSUE: Hospira, Inc. is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP (NDC: 0409-6510-01, Lot 591053A, Expiry Date 1NOV2017), to the hospital/retail level due to a confirmed customer report for the presence of particulate matter within a single vial. The product is packaged in a carton containing 1x100 mL vial. The lot was distributed from August 2016 through September 2016 in the United States.

If particulate is administered to a patient, it may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response to the particulate. The risk is reduced by the possibility of detection, as the label contains a clear statement directing the physician to visually inspect the product for particulate matter and discoloration prior to administration.

BACKGROUND: Vancomycin Hydrochloride is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant staphylococci.

RECOMMENDATION: Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. Inform health care professionals in your organization of this recall. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Further, please instruct entities that may have received the recalled product from you that if they redistributed the product, they should notify their accounts, locations or facilities of the recall to the hospital/retail level. Hospira will be notifying its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle in the United States.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the Medwatch safety alert, including a link to the press release, at:
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm538219.htm

Lifepak 1000 Defibrillators by Physio-Control: Voluntary Field Action - Immediately Remove and Reinstall Battery (1/24/2017)

ISSUE: Physio-Control announced that the company is launching a voluntary field action for the LIFEPAK 1000 defibrillator due to reported instances where the device has shut down unexpectedly during patient treatment.  

The company has received 34 reports where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to an intermittent connection between the battery and device electrical contacts. A defibrillator in this scenario may not be able to deliver therapy during a resuscitation attempt, which may expose patients to the risk of serious harm or death. The company is aware of 8 adverse events related to this issue.  

BACKGROUND: The company has determined that this intermittent connection is a result of wear and subsequent oxidation formation between the battery and device electrical contacts. This condition can occur over time in LIFEPAK 1000 devices that are exposed to vibration and have a battery installed for long periods of time. This issue can potentially affect any LIFEPAK 1000 device, however customers with non-rechargeable batteries who do not routinely remove the battery for inspection, as indicated in the LIFEPAK 1000 Defibrillator Operating Instructions, are more susceptible to this issue.  

RECOMMENDATION: The company is contacting customers and advising them to immediately remove and reinstall the battery from their device(s). Customers are also being advised to implement a weekly schedule of battery removal and reinstallation for all LIFEPAK 1000 devices. The removal and reinstallation of the battery will clean the contacts of oxidation and will reduce the likelihood of this issue from occurring. Physio-Control will be initiating a hardware device correction for all affected LIFEPAK 1000 devices and the company will contact customers to schedule device corrections once the hardware correction is ready for implementation.  

Information about this notice is available at: www.physio-control.com/lifepak1000-274. Affected customers will be notified by letter. Customers with questions regarding this notification, please contact Physio-Control by calling 1-866-231-1220, 6:00 a.m. to 4:00 p.m. (Pacific) Monday – Friday, or by email to rsrecalls@physio-control.com or fax to 1-866-448-9567.    

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:  
Complete and submit the report Online: www.fda.gov/MedWatch/report   

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

View the MedWatch Safety Alert, including a link to the Voluntary Field Report, at: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm537116

Nurse Assist Inc. Recalls Normal Saline Flush IV Syringes Due to Possible Burkholderia Cepacia Bloodstream Infections (1/5/2017)

Recalled Product:

  • Product Name: Normal Saline Flush
  • Product Description: 12 mL IV Flush Syringe with a 3 mL, 5 mL, or 10 mL fill volume
  • Product Codes: All lots of product codes: 1203, 1205, 1210 and 1210-BP
  • Manufacturing Dates: September 24, 2015 to August 1, 2016
  • Distribution Dates: February 16, 2016 to September 30, 2016
  • Devices Recalled in the U.S.: 386,175 syringes nationwide

Device Use

The normal saline flush is a plastic syringe filled with 0.9% Sodium Chloride. It is used to clear out medical devices that deliver medicine directly into the veins of a patient through a needle or catheter. These syringes are used by health care providers in hospitals or clinics before and after a drip medication is connected to a patent.

Reason for Recall

Nurse Assist Inc. is recalling the normal saline flush syringes due to incidents of Burkholderia cepacia (B. cepacia) contamination. B. cepacia is a bacterium that can cause bloodstream infections, particularly in patients with weak immune systems.

According to the U.S. Centers for Disease Control and Prevention (CDC), the effects of Burkholderia cepacia on people "vary widely, ranging from no symptoms at all to serious respiratory infections, especially in patients with cystic fibrosis."

The use of affected products may cause serious adverse health consequences including bloodstream bacterial infections and death.

Who May be Affected

  • Health care providers using the normal saline flush syringe
  • All patient groups undergoing procedures involving devices that were cleared out by the normal saline flush syringe

What to Do

On October 5, 2016, Nurse Assist, Inc. sent a certified mail notification to all affected customers. The notice asked customers to:

  • Immediately discontinue the use of any affected products
  • Complete the Medical Device Recall Return response form
  • Return any affected products along with the response form to suppliers via the Returned Goods Authorization provided by Nurse Assist, Inc.
  • For freight collect shipping information, customers should contact the Customer Service Team at 1-800-649-6800 ext. 10.

Contact Information

Customers with questions are instructed to contact Nurse Assist Inc. by telephone at 1-800-649-6800 ext. 10, Monday through Friday, between the hours of 8am and 5pm, Central Time. Consumers may also contact the company via email at ProductRemovalInfo@nurseassist.com.

Date Recall Initiated:

October 4, 2016

Additional Resources

Nurse Assist Inc. press release - Nurse Assist Initiates Voluntary Recall of IV Flush Syringes disclaimer icon

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.

Skintact DF29N Multi-function Defibrillation Electrodes by Leonhard Lang: Class I Recall - Connector Compatibility Issue (10/18/2016)

ISSUE: The Leonhard Lang defibrillation electrode is being recalled due to a connector compatibility issue with the Welch Allyn AED model 10. The user may not be able to connect the electrodes to the defibrillator when a shock is needed. This may result in a delay in delivering the electrical therapy needed to revive a patient in cardiac arrest.
A delay in therapy could result in serious patient injury and/or death.
Recalled product details:

  • 50028 Defibrillation Electrode SKINTACT DF29N
  • Lot Numbers: 60602-0774, 60502-0779, 60308-0771,60114-0773, 51023-0775, 50904-0777, 50403-0778, 50130-0777, 41023-0771, 41008-0778 40730-0778, 40618-0778, 40130-0776
  • Distribution Dates: February 14, 2014, to August 3, 2016

BACKGROUND: Automatic external defibrillators (AEDs) are used to deliver lifesaving electrical shocks to people with sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating.  Defibrillation electrodes are connected to the AED to help the device analyze a patient’s heart rhythm and deliver an electrical shock to restore normal heart rhythm when needed.

RECOMMENDATION: On September 1, 2016, Leonhard Lang sent an "Important Safety Notice" letter to all affected customers. The letter asked customers to:

  • Review the safety notice and ensure appropriate staff is aware of the notice.
  • Make sure all unused defibrillation electrodes DF29N are secured and destroyed.
  • Confirm the products were destroyed by completing the "Confirmation of Destruction / Consumption" form in the notice.
  • Send the "Confirmation of Destruction / Consumption" form to their supplier no later than October 14, 2016.
  • Keep the signed "Confirmation of Destruction / Consumption" form until their supplier informed them of the termination of this recall.

Health care professionals and consumers with questions are instructed to contact the Leonhard Lang sales staff at (800) 903-6199 with any questions related to this recall.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA recall notice, at:
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm525273.htm

Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) by St. Jude Medical: Batteries May Fail Earlier Than Expected (10/18/2016)

ISSUE: FDA and St. Jude Medical are alerting patients, patient-caregivers, and physicians to respond immediately to Elective Replacement Indicator (ERI) alerts. Due to problems with these batteries, patients do not have the normal 3-month lead time for device replacement. Some batteries have run out within 24 hours of the patient receiving an ERI alert. St. Jude Medical has initiated a recall and correction of the affected devices. See the FDA Safety Communication for a listing of affected devices and data summary.

St. Jude Medical has reported that in some cases, full battery drainage can occur within a day to a few weeks after the patient receives an ERI alert. If the battery runs out, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death. The patients most at risk are those with a high likelihood of requiring life-saving shocks and those who are pacemaker dependent.

Battery depletion may not always be reported to the manufacturer, therefore the true number of devices with premature battery depletion due to lithium clusters is not known. At this time, 349,852 affected devices remain actively implanted worldwide.

The FDA will continue to monitor affected St. Jude Medical ICD and CRT-D devices for any adverse events related to premature battery depletion or cybersecurity vulnerabilities, and the agency will keep the public informed as new information becomes available.

BACKGROUND: Implanted defibrillators (ICDs and CRT-Ds) are powered by lithium-based batteries. Deposits of lithium, known as “lithium clusters,” can form within the battery and create abnormal electrical connections leading to rapid battery failure.

RECOMMENDATIONS: See the FDA Safety Communication for a complete listing of recommendations for healthcare providers and patients. For healthcare professionals:

  • Do not implant unused affected devices. Premature battery depletion due to lithium clusters has only been observed in devices manufactured prior to May 2015. At this time, there is no information indicating that this issue affects devices manufactured after this date.
  • Communicate with all patients who have an affected device that their device has a battery that may run out earlier than expected. Consider giving patients the Dear Patient letter provided by St. Jude Medical.
  • Continue to conduct follow-up on patients with affected devices using in-office visits in addition to remote monitoring once they have been notified of the battery issue. Increased in-office surveillance is not necessary for patients who are also followed with remote monitoring.
  • Immediately replace the device at the time of an ERI alert. Currently, there is not a factor, method, or test to identify when devices with this form of premature battery depletion are approaching ERI, or to accurately predict remaining battery life once ERI appears.
  • Pacemaker-dependent patients with a device that has reached ERI should be treated as a medical emergency.
  • Health care providers should consider whether elective device replacement is warranted for their pacemaker dependent patients. Ultimately, health care providers should individualize the care of their patients based on the patients’ medical history, comorbidities and condition.
  • Most patients will not require prophylactic device replacement prior to ERI, as the rate of complications following replacement surgery are higher than those associated with premature battery depletion. However, the FDA and St. Jude Medical recognize the need to weigh individual clinical considerations. If the decision is made to replace an affected device based on individual patient circumstances, St. Jude Medical has announced they will provide a replacement device at no cost.
  • Enroll patients in Merlin@Home, St. Jude Medical’s home monitoring system for these devices, especially those who have difficulty recognizing their device’s ERI alerts. For patients already enrolled in Merlin@Home, explain the importance of ongoing home monitoring. Utilize the “Direct Alerts” feature to provide you with an alert notification when a patient’s device has reached ERI. Please see additional information about the Merlin@Home Monitoring System below. If a home monitor is ordered for a patient with an affected device, St. Jude Medical will cover the cost of the home monitor.
  • Ensure that the ERI battery alert is ON for all patients. Review the most recent “Programmed Parameters” printout.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert at:
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm524706.htm

Oxacillin for Injection, USP, 10g by Sagent: Recall - Iron Oxide Particulate Matter (8/26/2016)

ISSUE: Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of one lot of Oxacillin for Injection, USP, 10 g (NDC 25021-163-99) Lot OXT512 (Exp. Date March 2017) manufactured by Astral SteriTech Private Limited and distributed by Sagent. Sagent initiated this recall to the user level due to the receipt of a product complaint for a single vial containing small, dark particulate matter found within the solution after reconstitution. The particulate matter has been identified as iron oxide.

If metal particulate in an injectable product is administered to a patient, it may result in local swelling, irritation of blood vessels or tissue, or blockage of blood vessels. Blockage of blood vessels can lead to serious events, which may be life-threatening, such as stroke, heart attack, respiratory failure, kidney failure, or liver failure.

BACKGROUND: The product is packaged in cartons containing 10 x 10 gram Pharmacy Bulk Package bottles identified by NDC 25021-163-99. The lot number being recalled is Lot OXT512 which was distributed to hospitals, wholesalers and distributors nationwide from June 2016 through July 2016. Oxacillin for Injection, USP, 10 g is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. It is available by prescription only.

RECOMMENDATION: Customers are being notified by fax, email, FedEx, and/or certified mail that includes arrangements for the return of all recalled product. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lot of product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. The necessary form by which to document this information as well as other information regarding this recall is available at www.Sagentpharma.com.

Any questions about returning unused product should be directed to the Customer Call Center at 866.625.1618 M–F 8 a.m.–7 p.m. CST. Healthcare workers who have medical questions about Oxacillin for Injection, USP may contact Sagent Medical Affairs (866.625.1618, Option 3) M–F 8 a.m.–5 p.m. CST.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1.800.332.1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1.800.FDA.0178

Read the MedWatch safety alert, including a link to the press release, at:
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm517409.htm

Eyesaline Eyewash by Honeywell: Recall - Microbial Contamination (8/25/2016)

ISSUE: Honeywell is voluntarily recalling one production lot of 32-ounce bottles of Eyesaline Eyewash solution, which is used for emergency eye rinsing after an injury. Although no injuries have been reported and no contamination was found in batch testing, there is a risk of product contamination with Klebsiella pneumoniae. Although found in the normal flora of the mouth and skin, if the contaminant were present in a bottle, there is a potential for it to result in infections that may be sight-threatening.

Approximately 9,700 32-ounce bottles with lot number F16091-61 are subject to recall. No other lot number of the product is subject to this recall.

BACKGROUND: Eyesaline Eyewash is sold through industrial sales distributors. The affected product and lot number can be identified as follows:

  • Product: 32 ounce Eyesaline Eyewash
  • Lot number:  F16091-61 (no other lot number is subject to recall)
  • The lot number can be found on the outside of the product case, and on individual bottles. See the press release for product photos.

RECOMMENDATION: All of Honeywell’s distributors who received this lot have been notified by phone, e-mail and certified mail, and have been instructed to notify their customers. Distributors must stop distribution of the affected product and return it to Honeywell for credit or replacement. Commercial-industrial users of the product should also check whether their Eyesaline Eyewash is subject to recall. If it is, customers should stop using the solution and contact their distributor for replacement or credit.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the press release, at:
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm517484.htm

Fluoroquinolone Antibacterial Drugs for Systemic Use: Drug Safety Communication - Warnings Updated Due to Disabling Side Effects (7/29/2016)

Including the following currently available fluoroquinolones
Avelox (moxifloxacin)
Cipro (ciprofloxacin)
Cipro extended-release (ciprofloxacin extended-release)
Factive (gemifloxacin)
Levaquin (levofloxacin)
Ofloxacin (generic brand)

ISSUE: FDA approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, FDA revised the Boxed Warning, FDA’s strongest warning, to address these serious safety issues. In addition, FDA updated other parts of the drug label including the Warnings and Precautions and Medication Guide sections.

FDA has determined that fluoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections because the risk of these serious side effects generally outweighs the benefits in these patients. For some serious bacterial infections the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option.

FDA is continuing to assess safety issues with fluoroquinolones as part of FDA’s usual ongoing review of drugs and will update the public if additional actions are needed. See the FDA Drug Safety Communication for additional information, including a Data Summary and Additional Information for Health Care Professionals and Patients.

BACKGROUND: The labels of fluoroquinolone medicines already have a Boxed Warning for tendinitis, tendon rupture, and worsening of myasthenia gravis. The labels also include warnings about the risks of peripheral neuropathy and central nervous system effects. Other serious risks associated with fluoroquinolones are described in the labels, such as cardiac, dermatologic, and hypersensitivity reactions. After FDA’s 2013 review that led to the additional warning that peripheral neuropathy may be irreversible, FDA evaluated post-marketing reports of apparently healthy patients who experienced disabling and potentially permanent side effects involving two or more body systems after being treated with a systemic fluoroquinolone

RECOMMENDATION: Patients must contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include unusual joint or tendon pain, muscle weakness, a “pins and needles” tingling or pricking sensation, numbness in the arms or legs, confusion, and hallucinations. Talk with your health care professional if you have any questions or concerns (see List of Serious Side Effects from Fluoroquinolones in the FDA Drug Safety Communication).

Health care professionals should not prescribe systemic fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risks outweigh the benefits in these patients. Stop fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.

Over-the-Counter Antacid Products Containing Aspirin: FDA Drug Safety Communication - Serious Bleeding Risk (6/10/2016)

AUDIENCE: Consumer

ISSUE: The FDA is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. Many other products for these conditions are available that do not contain aspirin.
These widely used products already contain warnings about this bleeding risk on their labels; however, we are continuing to receive reports of this serious safety issue. As a result, we will continue to evaluate this safety concern and plan to convene an advisory committee of external experts to provide input regarding whether additional FDA actions are needed.

BACKGROUND: OTC aspirin-antacid products are sold under various trade names, including Alka-Seltzer Original, Bromo Seltzer, Medique Medi Seltzer, Picot Plus Effervescent, Vida Mia Pain Relief, Winco Foods Effervescent Antacid and Pain Relief, and Zee-Seltzer Antacid and Pain Reliever. They are also available as generic products.
In 2009, a warning about the risk of serious bleeding was added to the labels of all OTC products that contain NSAIDs, including aspirin-containing antacid products. However, a search of the FDA Adverse Event Reporting System (FAERS) database identified eight cases of serious bleeding events associated with these products after the warning was added. All of these patients were hospitalized. Patients had underlying conditions such as the risk factors above that put them at greater risk for developing serious bleeding events (see Data Summary). The FAERS database includes only reports submitted to FDA so there are likely additional cases about which we are unaware.

RECOMMENDATION: Consumers should always read the Drug Facts label carefully when purchasing or taking an OTC product to treat heartburn, acid indigestion, or sour or upset stomach. If the product contains aspirin, consider whether you should choose a product without aspirin to relieve your symptoms.
Aspirin is a commonly used pain reducer and fever reducer. It is a nonsteroidal anti-inflammatory drug (NSAID) that can increase the risk of bleeding, including in the stomach and gastrointestinal (GI) tract. Ask your pharmacist if you need help reading the Drug Facts label.
If you have one or more of the following risk factors, you may have a higher chance of serious bleeding when taking aspirin-containing antacid products:

  • Are 60 years or older
  • Have a history of stomach ulcers or bleeding problems
  • Take a blood-thinning or steroid medicine
  • Take other medicines containing NSAIDs such as ibuprofen or naproxen
  • Drink three or more alcoholic drinks every day

Taking more of these medicines than the amount recommended or for a longer period than recommended will increase the risk of serious bleeding.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm505190.htm

Loperamide (Imodium): Drug Safety Communication - Serious Heart Problems With High Doses From Abuse and Misuse (6/10/2016)

AUDIENCE: Pharmacy, Cardiology, Internal Medicine, Pain Management, Consumer

ISSUE: FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death. The risk of these serious heart problems, including abnormal heart rhythms, may also be increased when high doses of loperamide are taken with several kinds of medicines that interact with loperamide (see Examples of Drugs that Can Potentially Interact with Loperamide, in the FDA Drug Safety Communication).

The majority of reported serious heart problems occurred in individuals who were intentionally misusing and abusing high doses of loperamide in attempts to self-treat opioid withdrawal symptoms or to achieve a feeling of euphoria. FDA continues to evaluate this safety issue and will determine if additional FDA actions are needed.

BACKGROUND: Loperamide is approved to help control symptoms of diarrhea, including Travelers’ Diarrhea. The maximum approved daily dose for adults is 8 mg per day for OTC use and 16 mg per day for prescription use. It is sold under the OTC brand name Imodium A-D, as store brands, and as generics. See the FDA Drug Safety Communication for data summary.

RECOMMENDATION: Health care professionals should be aware that use of higher than recommended doses of loperamide can result in serious cardiac adverse events. Consider loperamide as a possible cause of unexplained cardiac events including QT interval prolongation, Torsades de Pointes or other ventricular arrhythmias, syncope, and cardiac arrest. In cases of abuse, individuals often use other drugs together with loperamide in attempts to increase its absorption and penetration across the blood-brain barrier, inhibit loperamide metabolism, and enhance its euphoric effects. If loperamide toxicity is suspected, promptly discontinue the drug and start necessary therapy. If loperamide ingestion is suspected, measure blood levels, which may require specific testing. For some cases of Torsades de Pointes in which drug treatment is ineffective, electrical pacing or cardioversion may be required. Refer patients with opioid use disorders for treatment (see Additional Information for Health Care Professionals in the FDA Drug Safety Communication).
Patients and consumers should only take loperamide in the dose directed by their health care professionals or according to the OTC Drug Facts label. Do not use more than the dose prescribed or listed on the label, as doing so can cause severe heart rhythm problems or death.

If your diarrhea lasts more than 2 days, stop taking loperamide and contact your health care professional. Seek medical attention immediately by calling 911 if you or someone taking loperamide experiences any of the following:

  • Fainting
  • Rapid heartbeat or irregular heart rhythm
  • Unresponsiveness, meaning that you can’t wake the person up or the person doesn’t answer or react normally 

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm505303.htm

Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Clinical Trial Results Find Increased Risk of Leg and Foot Amputations

ISSUE: FDA is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (Invokana, Invokamet). FDA has not determined whether canagliflozin increases the risk of leg and foot amputations. FDA is currently investigating this new safety issue and will update the public when we have more information.
See the FDA Drug Safety Communication for additional details regarding the ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS) clinical trial.

BACKGROUND: Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through the urine. It is available as a single-ingredient product under the brand name Invokana and also in combination with the diabetes medicine metformin under the brand name Invokamet.

RECOMMENDATION: Health care professionals should follow the recommendations in the canagliflozin drug labels. Monitor patients for the signs and symptoms described above and advise patients to seek medical advice if they experience them.

Patients should not stop or change their diabetes medicines without first talking to their health care professional. Doing so can lead to uncontrolled blood sugar levels that can be harmful. Over time, this can cause serious problems, including blindness, nerve and kidney damage, and heart disease. Patients taking canaglifozin should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1.800.332.1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1.800.FDA.0178

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm501565.htm

 

Dialog+ Hemodialysis Systems by B. Braun Medical: Class I Recall - Defective Conductivity Sensors (5/5/2016)

AUDIENCE: Risk Manager, Nephrology

ISSUE: B. Braun Medical Inc. is recalling the Dialog+ Hemodialysis System due to cracks in conductivity sensors that may allow air to enter into the solution (dialysis fluid or dialysate) used to help filter waste and other excess fluids in the blood. The presence of air in dialysis fluid may lead to improper blood filtration, causing serious adverse health consequences, including death.
The recalled products include

  • Model numbers: 710200L, 710200K, 710200S, 710200U, 710500L, 710500K
  • Manufacturing dates: April 1, 2013 to July 3, 2013
  • Distribution dates: June 25, 2013 to October 7, 2015

BACKGROUND: The Dialog+ Hemodialysis System is a machine used in the treatment of chronic kidney disease for patients whose own kidneys are no longer healthy enough to filter their blood of wastes and excess fluid. These systems are used in hospitals, health centers, and in outpatient dialysis center settings.

RECOMMENDATION: On April 1, 2016, B. Braun Inc. sent an “Urgent Medical Device Correction” letter to affected customers asking them to:

  • Inform all other potential users about the issue
  • Identify affected units in their inventory
  • Have a qualified service technician run a pressure test using the instructions attached with the letter
  • Tag the machine and continue its use if no drop in pressure was identified
  • Contact B. Braun Inc. customer service at 1-800-848-2066 for part replacement if air leakage was identified
  • Return a “Medical Device Correction Acknowledgment” form by email to PA_QualityAssurance.BBMUS_Service@bbraun.com or by fax to 610-849-1197

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch alert, including a link to the FDA Class I Recall Notice, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm499143.htm

Metformin-containing Drugs: Drug Safety Communication - Revised Warnings for Certain Patients With Reduced Kidney Function (4/11/2016)

AUDIENCE: Pharmacy, Nephrology, Internal Medicine, Patient

ISSUE: FDA is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin’s use in certain patients with reduced kidney function. The current labeling strongly recommends against use of metformin in some patients whose kidneys do not work normally. FDA was asked to review numerous medical studies regarding the safety of metformin use in patients with mild to moderate impairment in kidney function, and to change the measure of kidney function in the metformin drug labeling that is used to determine whether a patient can receive metformin.

FDA concluded, from the review of studies published in the medical literature, that metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function. FDA is requiring changes to the metformin labeling to reflect this new information and provide specific recommendations on the drug’s use in patients with mild to moderate kidney impairment.

FDA is also requiring manufacturers to revise the labeling to recommend that the measure of kidney function used to determine whether a patient can receive metformin be changed from one based on a single laboratory parameter (blood creatinine concentration) to one that provides a better estimate of renal function (i.e., glomerular filtration rate estimating equation (eGFR)). This is because in addition to blood creatinine concentration, the glomerular filtration rate takes into account additional parameters that are important, such as the patient’s age, gender, race and/or weight. See the FDA Drug Safety Communication for additional information, including a data summary and a list of metformin-containing drugs.

BACKGROUND: Metformin-containing medicines are available by prescription only and are used along with diet and exercise to lower blood sugar levels in patients with type 2 diabetes. When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. Metformin-containing medicines are available as single-ingredient products and also in combination with other drugs used to treat diabetes. The current drug labeling strongly recommends against metformin use in some patients whose kidneys do not work normally because use of metformin in these patients can increase the risk of developing a serious and potentially deadly condition called lactic acidosis, in which too much lactic acid builds up in the blood.

RECOMMENDATION: Healthcare professionals should follow the latest recommendations when prescribing metformin-containing medicines to patients with impaired kidney function. Patients should talk to their health care professionals if they have any questions or concerns about taking metformin.

The labeling recommendations on how and when kidney function is measured in patients receiving metformin will include the following information: 

  • Before starting metformin, obtain the patient’s eGFR.
  • Metformin is contraindicated in patients with an eGFR below 30 mL/minute/1.73 m2.
  • Starting metformin in patients with an eGFR between 30-45 mL/minute/1.73 m2 is not recommended.
  • Obtain an eGFR at least annually in all patients taking metformin. In patients at increased risk for the development of renal impairment such as the elderly, renal function should be assessed more frequently.
  • In patients taking metformin whose eGFR later falls below 45 mL/minute/1.73 m2, assess the benefits and risks of continuing treatment.  Discontinue metformin if the patient’s eGFR later falls below 30 mL/minute/1.73 m2.
  • Discontinue metformin at the time of or before an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/minute/1.73 m2; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast.  Re-evaluate eGFR 48 hours after the imaging procedure; restart metformin if renal function is stable. 

Read the MedWatch safety alert, including a link to the full Drug Safety Communication, at: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm494829.htm

OxySure Portable Emergency Oxygen System, Model 615 by OxySure Therapeutics, Inc.: FDA Safety Communication - Do Not Use (3/30/2016)

ISSUE: The FDA is recommending consumers, businesses, schools, and healthcare providers stop using OxySure Portable Emergency Oxygen System, Model 615 because of several device malfunctions, including ineffective oxygen delivery, and chemical reactions in the canisters that could cause them to explode.
Due to adverse event reports to the FDA and the company’s failure to address the device’s safety issues noted during inspections and in the FDA’s warning letter, the FDA is concerned that patients and other users of OxySure Portable Emergency Oxygen System, Model 615 are at risk for serious adverse health consequences, such as burns and death.
The FDA will continue to work with OxySure Therapeutics, Inc. to bring these devices into regulatory compliance and will keep the public informed if significant new information becomes available.

BACKGROUND: OxySure Portable Emergency Oxygen System is intended to produce oxygen for emergency use.
Since June 2013, OxySure Therapeutics, Inc. has distributed at least 1,000 units of the OxySure Portable Emergency Oxygen System, Model 615 nationwide. These devices may be purchased without a prescription and can be used in businesses, schools, and other public places (e.g., gyms, shopping malls, and airports). See the FDA Safety Communication for additional information.

RECOMMENDATION: The FDA recommends customers stop using the OxySure Portable Emergency Oxygen System, Model 615 and immediately transition to an alternative FDA-cleared emergency oxygen device.

Read the MedWatch safety alert, including a link to the FDA Safety Communication, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm492970.htm

Sodium Bicarbonate Injection, USP by Hospira: Recall - Particulate Matter (3/22/2016)

AUDIENCE: Pharmacy, Nursing

ISSUE: Hospira, Inc. is recalling one lot of 8.4% Sodium Bicarbonate Injection, USP (NDC: 0409-6625-02, Lot 56-148-EV, Expiry 1AUG2017) at the hospital/retail level due to the presence of a particulate within a single–dose glass fliptop vial. The issue was identified through a confirmed complaint.

The product is packaged 50 mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50mL, Single-dose, packaged 4 boxes of 25 vials per case. The lot was distributed nationwide in the U.S. to wholesalers and hospitals in December 2015.

If the particulate is not observed prior to IV administration and breaks off into smaller particulates, passing through the catheter, it may result in localized inflammation, allergic reaction, including anaphylaxis, granuloma formation or microembolic effects (IV only). Larger particulates may block the infusion of solution, potentially resulting in a delay in therapy.

BACKGROUND: Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis; in the treatment of certain drug intoxications, in poisoning by salicylates or methyl alcohol and in certain hemolytic reactions. Sodium bicarbonate also is indicated in severe diarrhea, which is often accompanied by significant loss of bicarbonate.

RECOMMENDATION: Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. Inform Healthcare Professionals in your organization of this recall. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Further, please instruct entities that may have received the recalled product from you that if they redistributed the product, they should notify their accounts, locations or facilities of the recall to the hospital/retail level. Hospira will be notifying its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle in the United States. For additional assistance, call Stericycle at 1-888-965-6077 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday. For clinical inquiries, please contact Hospira using the information provided in the press release.

Read the MedWatch safety alert, including a link to the press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm491506.htm

Baxter Initiates Voluntary Recall of Two Lots of IV Solutions due to Potential Presence of Particulate Matter (1/7/2016)

Audience:  ESRD Networks and Facilities

Issue:  FDA Safety Alert

Recall–Firm Press Release

Baxter International Inc. announced today it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital/end user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint. The matter was identified prior to patient administration and there have been no adverse events associated with this issue reported to Baxter to date.

Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs.

To read the complete FDA Safety Alert, click here.

CDC/FDA Health Update about the Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices (10/15/2015)

Summary
On September 11, 2015, CDC issued  HAN 00382 alerting healthcare providers and facilities about the public health need to properly maintain, clean, and disinfect or sterilize reusable medical devices.  Recent infection control lapses due to non-compliance with recommended reprocessing procedures highlight a critical gap in patient safety. Healthcare facilities (e.g., hospitals, ambulatory surgical centers, clinics, and doctors’ offices) that utilize reusable medical devices are urged to immediately review current reprocessing practices at their facility to ensure they (1) are complying with all steps as directed by the device manufacturers, and (2) have in place appropriate policies and procedures that are consistent with
current standards and guidelines.

After considering feedback from vendors that perform servicing and repair of reusable medical devices, we are amending HAN Advisory 382 to remove the following sentence: “If healthcare facilities contract maintenance and repair of these devices to third-party vendors, healthcare facilities should verify that these vendors are approved or certified by the manufacturer to provide those services.” We are making this change because there are currently no formal standardized programs or processes through which all manufacturers certify third-party vendors. We are also further clarifying that healthcare facilities which hire contractors to perform device reprocessing should verify that the contractor has an appropriate training program (i.e., consistent with what would be required in the healthcare facility) and that the training program includes the specific devices used by the healthcare facility. 

Click here for more information.

Baxter Initiates Voluntary Nationwide Recall of One Lot of IV Solution Due to the Potential For Leaking Containers, Particulate Matter and Missing Port Protectors (8/4/2015)

FOR IMMEDIATE RELEASE – July 30, 2015 – Deerfield, Illinois – Baxter International Inc. announced today it is voluntarily recalling one lot of intravenous (IV) solution to the hospital/user level due to the potential for leaking containers, particulate matter and missing port protectors. Baxter was made aware of these issues through customer complaints. There have been no adverse events associated with this lot reported to Baxter to date.

Leaking containers, particulate matter and missing port protectors could result in contamination of the solution. If not detected, this could lead to a bloodstream infection or other serious adverse health consequences. Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs.

Click here for more information.

Baxter Initiates Voluntary Recall Of Two Lots Of IV Solutions Due To The Potential Presence Of Particulate Matter 97/27/15)

AUDIENCE:Risk Manager, Pharmacy, Nursing

ISSUE: Baxter International Inc. announced it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint. The matter was identified prior to patient administration and there have been no adverse events associated with this issue reported to Baxter.

Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs.

This recall affects Lot Numbers P319921 and P327635.

BACKGROUND: The lots being recalled were distributed to customers and distributors in the United States between October 7, 2014 and July 14, 2015.

RECOMMENDATION: Baxter is directing customers not to use product from the recalled lots. Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., Central Time. Unaffected lots of product are available for replacement.
Consumers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time, or e-mail Baxter at onebaxter@baxter.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.

[07/17/2015 - Press Release - Baxter]

FDA Enforcement Report, NaturaLyte Liquid Bicarbonate Concentrate (7/16/2015)

Audience: ESRD Networks and Facilities

Issue: FDA Enforcement Report

Enforcement Report–Week of July 1, 2015

Product Description: NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

Recall Number: Z-1827-2015

Classification: Class II

Code Info: Affected lots begin with: 14DMLB, 14EMLB, 14HMLB, 14JMLB, 14KMLB, 14LMBL, 14NMLB, 14PMLB, and 14SMLB.

Reason for Recall: Bacterial contamination.

For the complete FDA Enforcement Report, click here.

Baxter Initiates Voluntary Recall of Select Lots of IV Solutions Due to the Potential Presence of Particulate Matter (4/9/2015)

Contact:
Consumer:
888-229-0001

Media:
John O’Malley
224-948-5353
media@baxter.com

Investors:
Mary Kay Ladone
224-948-3371
Clare Trachtman
224-948-3085

FOR IMMEDIATE RELEASE — April 9, 2015 — Deerfield, IL — Baxter International Inc. announced today it is voluntarily recalling select lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter. Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the size, number, and composition of the foreign material, and patient’s underlying medical condition. In the absence of in-line filtration, these particles may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization. In high-risk patients this may lead to serious adverse health consequences.

While Baxter manufacturing personnel were performing routine maintenance, particulate matter was detected and identified as material from a solution transmission system pump. There have been no adverse events or product complaints associated with this issue reported to Baxter.

Sodium Chloride Injection, USP is indicated as a source of water and electrolytes and for use as a priming solution in hemodialysis procedures. Dextrose Injection, USP is indicated as a source of water and calories. Lactated Ringer’s Injection, USP is indicated as a source of water and electrolytes, or as an alkalinizing agent. The lots being recalled were distributed to customers and distributors in the United States and Bermuda between January 14, 2015 and March 5, 2015.

Baxter began the customer notification process on March 24, 2015. Customers have been directed not to use products from the recalled lots. Recalled products should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., Central Time. Unaffected lots of product are available for replacement.

Consumers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time, or e-mail Baxter at onebaxter@baxter.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

For a list of the recalled products click here.

Feraheme (ferumoxytol): Drug Safety Communication – Warnings Strengthened and Prescribing Instructions Changed (3/31/2015)

AUDIENCE: Hematology, Nephrology, Pharmacy

ISSUE: FDA is strengthening an existing warning that serious, potentially fatal allergic reactions can occur with the anemia drug Feraheme (ferumoxytol). FDA changed the prescribing instructions and approved a Boxed Warning, FDA’s strongest type of warning, regarding these serious risks. Also added is a new Contraindication, a strong recommendation against use of Feraheme in patients who have had an allergic reaction to any intravenous (IV) iron replacement product.

All IV iron products carry a risk of potentially life-threatening allergic reactions. At the time of Feraheme’s approval in 2009, this risk was described in the Warnings and Precautions section of the drug label. Since then, serious reactions, including deaths, have occurred despite the proper use of therapies to treat these reactions and emergency resuscitation measures (see Drug Safety Communication/Data Summary). FDA evaluated this risk further and has identified ways to reduce the risk of serious allergic reactions with Feraheme.

FDA is continuing to monitor and evaluate the risk of serious allergic reactions with all IV iron products, and we will update the public as new information becomes available.

BACKGROUND: Feraheme is in a class of medicines called IV iron replacement products. It is used to treat iron-deficiency anemia―a condition in which there is a lower than normal number of oxygen-carrying red blood cells because of too little iron. Feraheme is specifically approved for use only in adults with iron deficiency anemia in patients with chronic kidney disease.

RECOMMENDATIONS: Based on FDAs evaluation, the prescribing instructions and other label information were updated, adding a Boxed Warning that describes these serious risks and recommending that health care professionals:

  • Only administer IV iron products to patients who require IV iron therapy.
  • Do not administer Feraheme to patients with a history of allergic reaction to Feraheme or other IV iron products.
  • Only administer diluted Feraheme as an IV infusion over a minimum of 15 minutes. Feraheme should not be given as an undiluted IV injection.
  • Closely monitor patients for signs and symptoms of serious allergic reactions, including monitoring blood pressure and pulse during Feraheme administration and for at least 30 minutes following each infusion.
  • Carefully consider the potential risks and benefits of Feraheme administration in elderly patients with multiple or serious medical conditions, as these patients may experience more severe reactions.
  • Carefully consider the potential risks and benefits of Feraheme administration in patients with a history of multiple drug allergies. Patients with multiple drug allergies may also be at higher risk.

LifeCare Flexible Intravenous Solutions by Hospira, Inc.: Recall - Potential for Leakage (10/20/2014)

AUDIENCE: Pharmacy, Nursing, Risk Manager

ISSUE: Hospira, Inc. announced the voluntary recall of certain lots of several products in its LifeCare line of flexible intravenous solutions due to the potential for leakage. The issue was identified during re-inspection of a manufactured product lot in which a single puncture mark was identified going through the overwrap and primary container. The puncture in the primary container may result in leakage that is difficult to detect. Leakage may result in an open system, which has the potential for contamination, compromised sterility, drug waste, spillage, inadequate or inconsistent solution/medication dosing, and/or delay in therapy, all of which may require medical intervention. Hazardous topical exposure may occur if a hazardous drug is added to the flexible container. To date there have been no reports of adverse events associated with this issue for the impacted lots.

BACKGROUND: The affected lots were originally distributed by Hospira to direct accounts from September 2013 through October 2014. The root cause is attributed to a defect in a conveyance system, and corrective actions have since been implemented to prevent a reoccurrence. The manufacturing issue that caused this incident has been addressed.

RECOMMENDATION: See the Firm Press Release for a list of the recalled lots. Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine the product immediately. Hospira will be notifying its direct customers via a recall letter and will arrange for impacted product to be returned to Stericycle. For additional assistance, call Stericycle at 1-844-861-6221 between the hours of 8am to 5pm ET, Monday through Friday.

Baxter Voluntarily Initiates U.S. Recall of Two Lots of Peritoneal Dialysis Solution Due to Presence of Particulate Matter (8/15/2014)

Contact:
Consumer:
1-800-284-4060

Media Contacts:
Deborah Spak
(224) 948-5353
Email: media@baxter.com

FOR IMMEDIATE RELEASE - DEERFIELD, Ill., - August 13, 2014 – Baxter International Inc. announced today it is voluntarily initiating a recall in the United States of two lots of DIANEAL Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000mL (Ambu-Flex II) to the hospital/user level. The recall is being initiated due to the presence of oxidized stainless steel, garment fiber, and PVC particulate matter identified during the manufacturing process.

To date, no adverse events or related product complaints have been associated with the recalled products, which were distributed to dialysis centers, facilities, distributors, and patients in the United States.

Intraperitoneal administration of a product with particulate matter may cause local inflammation with foreign body reaction or result in adhesion formation. The particulate matter could potentially serve as a focal point for infection should any pre-existing peritonitis exist, and may lead to a fatal outcome.

DIANEAL is a peritoneal dialysis (PD) solution for use in chronic renal failure patients being maintained on peritoneal dialysis therapy. PD therapy is performed by using the body’s peritoneal membrane as a filter, while special solution and osmotic pressure help remove extra fluids and clean the blood. This process takes the place of what healthy kidneys do for the body.

This recall affects the following lots of DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000 mL (Ambu-Flex II container):
The number of individual units within these two lots represents less than one percent of Baxter’s average annual units produced globally. Unaffected lot numbers can continue to be used according to the instructions for use.

Baxter notified customers by recall letter to instruct them to locate and remove any affected product from their facility. All patients who received product from the affected lots also were contacted by recall letter and provided instructions to arrange for product return. Dialysis centers, facilities, distributors, and patients should stop use and return to place of purchase. The affected lots were distributed to customers between May 30, 2014 and July 9, 2014.

Healthcare providers who received affected product should return it to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., Central Time. Unaffected lots of product are available for replacement.

Consumers with questions regarding this recall or requiring replacement product can call Baxter Home Care Services at 1-800-284-4060, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m. Central Time. Patients should contact their physician or PD nurse if they have experienced any problems that may be related to taking or using this drug product.

Any adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
According to the DIANEAL PD Solution product labeling, the container should be inspected visually for signs of leakage prior to use. Solutions that are cloudy, discolored, contain visible particulate matter, or show evidence of leakage should not be used.

About Baxter
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

Content from:   http://www.fda.gov/Safety/Recalls/ucm410010.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Class II Recalls of NxStage SAK Dialysate Concentrate (7/3/2014)

Recalls have been initiated for NxStage SAK Dialysate Concentrate containing aluminum levels which exceed internal product specification.  Please click here for lot-specific information.

Advocate Redi-Code+ Blood Glucose Test Strips by Diabetic Supply of Suncoast: Recall- Labeling Error (6/13/2014)

AUDIENCE: Consumer, Family Physician, Pharmacy

ISSUE: Diabetic Supply of Suncoast, Inc. initiated a nationwide voluntary recall of all BMB-BA006A Advocate Redi-Code+ blood glucose test strip lots manufactured by BroadMaster Bio-Tech Corp due to a labeling error which could result in confusion about which meter models the Redi-Code+ BMB-BA006A blood glucose test strips are designed to be used with. In the incorrect labeling, the test strips model (BMB-BA006A) was omitted. Suncoast is recalling the test strips in an effort to avoid confusion and the possible misuse of the Advocate Redi-Code+blood glucose test strips with the Taidoc meters listed in the Firm Press Release, which could result in incorrect glucose results.

Falsely high or falsely low glucose results could potentially cause missed or delayed hyperglycemia or hypoglycemia detection and lead to no treatment or inappropriate treatment. Delayed or inappropriate treatment of hyperglycemic or hypoglycemic states could lead to serious health consequences, including death.

BACKGROUND: Diabetic Supply of Suncoast, Inc. is notifying its wholesale Distributors, Pharmacies, Medical Supply stores, Health Care Providers and direct customers throughout the entire US and Virgin Islands by letter and Press Release about the specifics of the recall.

RECOMMENDATION: Customers who have the affected test strips can contact Diabetic Supply of Suncoast, Inc. directly for further information. Test strips will be replaced with relabeled boxes of test strips to avoid any chance of confusion. Consumers should stop using the above mentioned test strips and contact Suncoast to find out if this recall pertains to the test strips they have in their possession and if so how to have them replaced for the relabeled products manufactured by BroadMaster Bio-Tech.

Customers with questions may contact Diabetic Supply of Suncoast at (561) 296-0488 between the hours of 9:00AM and 5:00PM Monday through Friday Eastern standard time or view the information at www.dsosi.com.

Customers who have the Advocate Redi-Code blood glucose meters manufactured by Taidoc Technology Corp should follow the product User Manual for information about the appropriate test strips to be used with the Taidoc meters.

NaturaLyte Liquid Bicarbonate Concentrate: Recall - Potential Health Risk (5/22/2014)

AUDIENCE: Nephrology, Nursing

ISSUE: Fresenius Medical Care North America issued a recall notice for NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liters (intended for use in hemodialysis machines). Bacterial contamination of the dialysate may lead to bacteremia or systemic infection. The dialysis filter (dialyzer) and the use of the Diasafe filter or equivalent create an effective bacteria and endotoxin barrier that makes this event unlikely.

The affected lots are being recalled because they may develop higher bacteria levels than is allowed by the company’s internal specification during their shelf life.

BACKGROUND: Laboratory testing has identified the bacteria as Halomonas (species 1, 2, 3), a Gram Negative bacteria, typically found in water with high salinity (salt concentration).

RECOMMENDATION:  A list of the 56 lot numbers of product which should be permanently removed from use and returned is available at www.fmcna.com.  Customer notifications were published on April 10th and May 1st, 2014.

[05/21/2014 - Recall Notice - FDA]

Alaris Pump Module (Model 8100), Version 9.1.18 Software by CareFusion 303, Inc: Class I Recall - May Not Properly Delay an Infusion (5/21/2014)

AUDIENCE: Risk Manager, Biomedical Engineer, Nursing

ISSUE: CareFusion is recalling the Alaris Pump model 8100, version 9.1.18, because the pump may have a software failure where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose" feature is used. This issue does not impact the “Delay For” Option. The software failure also causes the pump to not properly deliver a multidose infusion as expected under certain conditions. See the FDA recall notice for more information.

Infusion start times earlier or later than intended could result in serious injury or death.

BACKGROUND: The Alaris Pump Model 8100 is a large volume infusion pump. The affected products were manufactured from February 6, 2014 to April 8, 2014 and distributed from February 7, 2014 through April 7, 2014. See the FDA recall notice for a listing of the affected serial numbers.

RECOMMENDATION: The firm recommends that the previous Alaris Pump module software version 9.1.17 be installed to address this recall. CareFusion will contact all affected customers to schedule the installation of software version 9.1.17. Do NOT use the Alaris Pump module “Delay Until” option. Do NOT use the “Multidose” feature.

As an interim guidance, customers may update their dataset to disable both Delay Options and/or Multidose across all Profiles to prevent the use of “Delay Until” option and/or “Multidose” feature. These are shared configurations with the Alaris Syringe module and if disabled would prevent use of these features with the Alaris Syringe module as well.

[05/20/2014 - Recall Notice - FDA]

Ventlab Resuscitator Bags: Recall - Possible Health Risk (5/20/2014)

AUDIENCE: Risk Manager, Emergency Medicine, Anesthesiology

ISSUE: Ventlab, LLC. initiated a voluntary medical device removal of certain Ventlab Resuscitator Bags after becoming aware of complaints regarding a sticking duckbill valve that resulted in the resuscitation bags delivering no air through the patient valve, to the patient. Resuscitation bags affected may not function properly and may result in a delay of treatment and life threatening health consequences that include hypoxia and hypoventilation. 

BACKGROUND: Please refer to the firm's press release for a list of recalled models.

RECOMMENDATION: Users who have resuscitation bags within the lot numbers listed in the firm's press release should stop using them and immediately contact Ventlab, LLC. for further instructions on the return of these products.

Ventlab, LLC. will notify its distributors and customers by a direct mailing and arrange for the return and replacement of all of the recalled resuscitation bags. Users with questions may contact Ventlab LLC. via telephone at 1-844-635-5326 between the hours of 8:30 AM to 5:00 PM (EST) Monday through Friday. Consumers may also contact the company via e-mail at PFA@ventlab.com.

[05/14/2014 - Recall Notice - FDA]

NxStage SAK Dialysate Concentrate Recall (5/20/2014)

NxStage issued a voluntary recall on May 15, 2014 regarding SAK Dialysate Concentrate.  Please click here to read the letter.

Contact Information: NxStage Medical, Inc. ▪ 350 Merrimack Street ▪ Lawrence, MA 01843 USA
tel: (978) 687-4700 ▪ fax: (978) 687-4800 ▪ www.nxstage.com

GenStrip Blood Glucose Test Strips by Shasta Technologies: FDA Safety Communication - May Report False Results (4/30/2014)

AUDIENCE: Pharmacy, Risk Manager, Patient

ISSUE: The FDA is advising people with diabetes and health care professionals to stop using GenStrip Blood Glucose Test Strips because the strips may report incorrect blood glucose levels.

During a recent inspection of Shasta Technologies LLC, the FDA found extensive violations of federal regulations intended to assure the quality of products in the manufacturing of GenStrip Test Strips. FDA found that Shasta Technologies did not have in place many of the requirements of a quality system. Without assurance of an adequate quality system, the FDA believes that the strips could report incorrect blood glucose levels.

BACKGROUND: GenStrip Blood Glucose Test Strips, sold by Shasta Technologies LLC, are "third-party" blood glucose monitoring test strips. Shasta’s GenStrips are advertised for use with the LifeScan OneTouch family of glucose meters (e.g. Ultra, Ultra 2 and Ultra Mini).

RECOMMENDATION: Discontinue use of GenStrip Blood Glucose Test Strips. FDA recommends the use of alternative glucose test strips that are designed for use with the LifeScan OneTouch family of glucose meters

[04/29/2014 - Safety Communication - FDA]

Lidocaine HCI Injection, USP, by Hospira: Recall - Visible Particulates (4/22/2014)

AUDIENCE: Pharmacy, Patient, Health Professional, Nursing

 ISSUE: Hospira, Inc. will initiate a voluntary recall of one lot of 1% Lidocaine HCI Injection, USP, 10mg/mL, 30 mL single dose, Preservative - Free to the user level due to a confirmed customer report of orange and black particulate within the solution and embedded within the glass vial. Hospira has identified the particulate as iron oxide. Risk factors associated with the particulate include the potential for particulate to be injected and/or a delay in therapy.

If the particulate or smaller pieces of the particulate that could break off, become free floating within the solution pass through the catheter into the patient, it may result in local inflammation, and/or mechanical disruption of tissue or immune response to the particulate. Chronically, following sequestration, local granuloma formulation may occur.

 BACKGROUND: This lot (Lot # 31-427-DK, Expiration Date 1JUL2015) was distributed nationwide to distributors/wholesalers, hospitals and clinics from September 2013 through October 2013.

 RECOMMENDATION: Anyone with existing inventory should immediately stop use and quarantine any affected product. In addition, customers should inform potential users of this product in their organizations of this notification. Hospira will be notifying its direct distributors/customers via a recall letter and will arrange for impacted product to be returned to Stericycle for returns processing. For additional assistance, call Stericycle at 1-888-835-2723. For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187.

[04/18/2014 - Firm Press Release - Hospira, Inc.]

CUBICIN (daptomycin for injection) by Cubist Pharmaceuticals: Recall - Presence of Particulate Matter (4/22/2014)

AUDIENCE: Pharmacy, Patient, Health Professional, Nursing

ISSUE: Cubist Pharmaceuticals, Inc. is voluntarily recalling one lot (Lot # 280453F) of CUBICIN (daptomycin for injection) 500 mg to the user level due to the presence of particulate matter, identified as glass particles.

The administration of glass particulate, if present in an intravenous drug, poses a potential safety risk to patients including: thromboembolism, pulmonary emboli, phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a glass particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material.

BACKGROUND: Cubicin is an intravenously administered prescription product indicated for the treatment of skin infections and certain blood stream infections. Cubicin was distributed Nationwide to multiple consignees.

RECOMMENDATION: Anyone with an existing inventory of the product lot listed should determine whether they have product from the recalled lot, quarantine and discontinue distribution of this recalled lot of the product and call Cubist at (855) 534-8309 to arrange for return and replacement of the affected lot.

[04/18/2014 - Firm Press Release - Cubist Pharmaceuticals, Inc.]

Urgent Medical Device Recalll: FMCNA NaturaLyte® Liquid Bicarbonate Concentrate (4/18/2014)

Click here for more information.

Hospira Hemostat Dual Channel Plum Set: Recall-Risk of over-delivery of blood products (3/21/2014)

AUDIENCE: Risk Manager, Nursing 

ISSUE: Hospira identified that an incorrect set component was
supplied and used during the manufacturing process of the impacted product lots. The Hemostat Dual Channel Plum Set is designed to administer blood and blood products via the Plum infusion pump. If the Plum infusion pump is used with the affected product, the blood product will be delivered at its intended dosage and there is no risk of over-delivery. If the affected product is removed from the Plum infusion pump and used in a gravity infusion, there is a risk that over-delivery may occur. Over-delivery of blood products in the populations at greatest risk (e.g. neonates, patients with heart and/or kidney failure, and other patients with conditions associated with susceptibility to volume overload) may result in injuries that require medical intervention. These injuries are expected to fully resolve with medical intervention.

BACKGROUND: The blood sets impacted by the recall (list number 11241-03, lot numbers 28005-5H and 34100-5H)were distributed to U.S. healthcare and veterinary facilities from May 2013 through Dec. 2013.

RECOMMENDATION: Customers should check inventory and immediately quarantine any affected product. In addition, customers should inform potential users of this product in their organizations of this notification. Affected product should be returned to Stericycle.

[3/18/2014 - Press Release - Hospira]

FreeStyle and FreeStyle Flash Blood Glucose Meter by Abbott: Recall - May Produce Mistakenly Low Blood Glucose Results (3/17/2014)

AUDIENCE: Consumer, Pharmacy

ISSUE: Abbott is conducting a recall for the FreeStyle Blood Glucose Meter and the FreeStyle Flash Blood Glucose Meter. When used with the Abbott FreeStyle test strips, the FreeStyle Blood Glucose Meter and the FreeStyle Flash Blood Glucose Meter may produce mistakenly low blood glucose results.

BACKGROUND: FreeStyle and FreeStyle Flash Blood Glucose Meters have not been in production since 2010. Abbott began notifying users on Feb. 19, 2014, immediately after the issue was discovered.

RECOMMENDATION: Abbott recommends the following actions for people with meters affected by this recall:

  • Immediately contact Abbott Diabetes Care at 1-888-345-5364 to obtain a replacement meter.
  • If the only meter available to you is an affected meter, continue to test your blood glucose as recommend by your doctor while you wait for your replacement meter. When using an affected meter, follow the precautions and recommendations in the press release. 
  • If you have access to an alternative glucose meter, immediately discontinue use of the affected meter and take the necessary steps to continue to monitor your blood sugar with the alternative meter.
  • For users of the OmniPod Insulin Management System with the built-in FreeStyle Blood Glucose Meter, refer to the Abbott recommended actions at https://www.abbottdiabetescare.com/press-room/2014/2014-b.html.

See the press release for additional information and recommendations.

[03/16/2014 - Press Release - Abbott]

DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5 Percent Dextrose 6000mL: Recall - Contamination With Mold (3/7/2014)

AUDIENCE: Pharmacy

ISSUE: Baxter International notified health professionals and their care organizations of the recall in the United States of a single lot of DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose 6000ml to the hospital/user level. The recall is being initiated as a result of complaints of particulate matter, identified as mold. The affected lot is C903799, expiration 05/15 (product code L5B9710), NDC 00941-0411-11. Product affected by this recall was packaged in flexible plastic containers and distributed to dialysis centers, facilities, distributors and patients in the United States between May 2013 and January 2014.

BACKGROUND: DIANEAL is a peritoneal dialysis (PD) solution for use in chronic renal failure patients being maintained on PD therapy.

RECOMMENDATION: Baxter notified customers by recall letter to instruct customers to locate and remove any affected product from their facility. All patients who received product from the affected lot also were contacted by recall letter and provided instructions to arrange for product return. Dialysis centers, facilities, distributors and patients should stop use and return to place of purchase.

As per product labeling, the container should be inspected visually for signs of leakage prior to use. Solutions that are cloudy, discolored, contain visible particulate matter, or show evidence of leakage should not be used.

[03/05/2014 - Firm Press Release - Baxter]

t:slim Insulin Cartridges by Tandem Diabetes Care: Recall - Potential for Cartridge Leak (1/15/2014)

AUDIENCE: Endocrinology, Patient, Health Professional

ISSUE:  Tandem Diabetes Care announced that it is initiating a voluntary recall of specific lots of insulin cartridges that are used with the t:slim Insulin Pump. The affected cartridges may be at risk for leaking. A cartridge leak could potentially result in the device delivering too much or too little insulin, which can lead to a serious adverse event.

BACKGROUND: Affected lots were shipped on or after December 17, 2013. The affected lots represent approximately 4,746 boxes of cartridges (10 cartridges per box).

RECOMMENDATION: Customers should discontinue using cartridges labeled with the affected lots.  Please see the Firm Press Release for the complete listing. Customers who received affected cartridges are being contacted by the company or its authorized distributors and asked to call Tandem Technical Support to receive replacement cartridges at no charge. Tandem expects to have sufficient quantities of cartridges to replace affected lots in a timely manner. Tandem Customer Support is available 24 hours a day, 7 days a week at 1-877-801-6901.

Nipro Diagnostics, Inc. Initiates Voluntary Recall of Certain TRUEbalance and TRUEtrack Blood Glucose Meters (1/9/2013)

AUDIENCE: Consumer, Pharmacy

ISSUE: Nipro Diagnostics initiated a voluntary recall and replacement of a limited number of TRUEbalance and TRUEtrack Blood Glucose Meters distributed both in the United States and outside the United States.

The company determined that certain isolated TRUEbalance and TRUEtrack Blood Glucose Meters have an incorrect factory-set unit of measure that displays the glucose result in mmol/L rather than mg/dl. If a consumer were not to notice the incorrect unit of measure, it is possible that the meter result could be read as a lower than expected blood glucose result.

BACKGROUND: There are 501 affected TRUEbalance meters and 105 affected TRUEtrack meters that were distributed in the United States from September 2008 to May 2013. The company is sending notifications to pharmacies, durable medical equipment providers, mail order companies and distributors where the TRUEbalance and TRUEtrack meters are recommended or sold in the United States.

RECOMMENDATION: Consumers who have a TRUEbalance or TRUEtrack meter should:

  • Check to confirm if they have an affected TRUEbalance or TRUEtrack meter by obtaining the serial number from the serial number label on the back of the meter and visiting www.NiproDiagnostics.com/product-notice or by calling Stericycle toll-free at 1-866-236-4518.
  • If the consumer has an affected TRUEbalance or TRUEtrack meter, please call Stericycle to verify serial number, and to expedite return and replacement of these affected TRUEbalance and TRUEtrack meters at no charge.

Consumers may continue to test blood glucose using any other Nipro Diagnostics blood glucose meter not included in this recall while waiting for their replacement meter to arrive. Only use test strips that are intended for use with their blood glucose meter.

Hospira Issues a Voluntary Nationwide Recall of One Lot of Lidocaine HCl Injection, USP, 2%, 5 Ml in 5 Ml Vial, Due to Presence of Particulate Matter (12/30/2013)

Contact
Consumer:
1-855-695-8596

Media:
224-212-2357

FOR IMMEDIATE RELEASE - December 23, 2013 - Hospira, Inc. (NYSE: HSP), announced today it will initiate a voluntary nationwide recall to the user level for one lot of Lidocaine HCl Injection, USP, 2%, 5 mL Single-Dose Vial (NDC 0409-2066-05), Lot 32-135-DD, expiration date 1AUG2015. The recall is due to a reddish orange particulate on the inner surface and floating in the solution.

If particulate goes undetected and solution is administered, the particle may potentially block the infusion of the solution to the patient, resulting in a delay in therapy. If smaller pieces of the particulate break off and become free floating within the solution, they may pass through the catheter into the patient, resulting in local inflammation or mechanical disruption of tissue. Chronically, following sequestration, local granuloma formulation is possible. In consideration of the reddish orange color of the particulate, if there is iron within the particle that is infused, it may put a patient at risk when undergoing MRI (strong magnetic field exposure), as the particle could potentially be dislodged and be pulled through tissue, causing local inflammation and tissue trauma.

Lidocaine is packaged 10 units per carton/180 units per case in single dose glass fliptop vials.

The recalled lot was distributed to distributors/wholesalers, hospitals, and pharmacies located in AL, AZ, CA, CO, FL, GA, HI, IL, IN, KY, LA, MD, MA, MI, MS, MO, NV, NJ, NC, OH, OK, PA, TN, TX, UT, VA, WA, and WI between September 2013 through October 2013. Hospira became aware of the issue after receiving a complaint of particles in the glass vial. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. Hospira believes the embedded particulate is related to a supplier’s glass defect.

Anyone with an existing inventory should immediately stop use and quarantine any affected product and return the product to Stericycle. Hospira will be notifying its direct distributors/customers via a recall letter and will arrange for impacted product to be returned to Stericycle for returns processing. For additional assistance, call Stericycle at 1-855-695-8596 between 8 a.m. and 5 p.m., ET, Monday through Friday.

For clinical inquiries, please contact Hospira using the information provided below.

Hospira Contact

Contact Information

Areas of Support

Hospira Global Complaint Management

1-800-441-4100 (8am-5pm CT, M-F) (ProductComplaintsPP@hospira.com)

To report adverse events or product complaints

Hospira Medical Communications

1-800-615-0187 or medcom@hospira.com (Available 24 hours a day/7 days per week)

Medical inquiries

Any adverse reactions or quality problems experienced with the use of this product may be reported to the U.S. Food and Drug Administration's (FDA) MedWatch Adverse Events Program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Hospira
Hospira, Inc. is the world's leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 16,000 employees. Learn more at www.hospira.com.
Content from: http://www.fda.gov/Safety/Recalls/ucm379313.htm

HeartStart Automated External Defibrillators (AED) From Philips Healthcare: Safety Communication - Failure Of An Electrical Component That Could Cause AEDs To Fail To Deliver Appropriate Shock - 12/4/2013

AUDIENCE: Risk Manager, Emergency Medicine, Health Professional

ISSUE: FDA issues safety communication on HeartStart automated external defibrillators from Philips Healthcare. Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation.  These devices were manufactured and distributed between 2005 and 2012 under the names HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite.

BACKGROUND: An AED is a device that automatically analyzes the heart rhythm in victims of sudden cardiac arrest and delivers an electrical shock to restore its normal rhythm. AEDs help save lives of cardiac arrest victims when they are working properly and used correctly.

In September 2012, Philips Healthcare initiated the recall of HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDs due to the failure of an internal electrical component. The recall affected approximately 700,000 devices. In a Medical Device Safety Notice dated November 19, 2013, Philips provided consumers with updated information about the failure of an internal electrical component that could cause the AEDs to fail to deliver a shock.

In March 2013, the FDA issued a proposed order that if finalized would require manufacturers of AEDs and accessories to submit premarket approval applications that focus specifically on the critical requirements necessary to assure AEDs are safe and effective. The main objective of this proposed regulatory approach is to improve the reliability of AEDs so that they can continue to save lives.

RECOMMENDATION: All owners of the Philips HeartStart AEDs should contact Philips Healthcare immediately at 1-800-263-3342, and select option 5 for technical support. Live technical support is available Monday – Friday, 7:00 am – 5:00 pm Pacific Time. All owners should keep the recalled HeartStart AED in service until Philips Healthcare replaces the device or you can obtain another working AED. If unsure if Philips HeartStart AED is affected by this recall or you received a replacement unit after the September 2012 recall notification, please contact Philips Healthcare for additional information. Please be aware that the Philips HeartStart AEDs are designed to automatically test themselves at regular intervals to ensure they are ready for use. The HeartStart AED should emit a triple chirp sound and have a flashing “i-button” if it detects a serious problem that could prevent the HeartStart AED from delivering an electrical shock.

Cefepime For Injection, USP And Dextrose Injection, USP By B. Braun Medical Inc.: Recall - Visible Particulate Matter - 10/16/2013

AUDIENCE: Pharmacy, Health Professional, Patient

ISSUE: B. Braun Medical Inc. is voluntarily recalling one lot of 1g Cefepime for Injection USP and Dextrose Injection USP (Lot H3A744, catalog 3193-11) to the consumer level. The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit. Visible particulate matter, including metals, and organic material such as cotton fibers or hair, may illicit inflammatory responses, both chronic and acute, and may be life threatening (e.g. systemic inflammatory response syndrome (SIRS and / or anaphylaxis). If a right to left cardiac shunt is present, the particulate may lead to arterial emboli and result in stroke, myocardial infarction, respiratory failure, and loss of renal and hepatic function or tissue necrosis. Other adverse effects associated with intravenous injection of particulate matter include foreign body granulomata, particularly in the lungs, and local irritation of blood vessels. B.Braun has not received any reports of adverse events related to this lot to date.

BACKGROUND: The product is used as a cephalosporin antibacterial indicated in the treatment of infections caused by susceptible strains of designated microorganisms. The product is packaged in a Duplex single dose intravenous, plastic container with 24 units per case. The affected lot H3A744, which expires January 2015, was distributed nationwide to licensed distributors, hospitals and pharmacies, and distributed to customers between the dates of February 4, 2013 and March 1, 2013

RECOMMENDATION: Patients reporting any problems that may be related to the use of this product should be advised to contact a physician and report all issues to B.Braun at 1-800-854-6851. B.Braun is notifying its distributors and customers by written, return receipt letters and is arranging for return of all recalled product. Distributors and customers that have inventory of the 1g Cefepime for Injection USP and Dextrose Injection USP of lot H3A744 should discontinue use immediately and contact  B.Braun’s Customer Support Department at 1-800-227-2862, Monday through Friday, 8 a.m. to 7 p.m. EST for instructions for returning the affected product and to arrange for replacement product.

1% Lidocaine HCL Injection By Hospira: Recall - Presence Of Dark Particulate - 10/7/2013

AUDIENCE: Health Professional, Risk Manager

ISSUE: Hospira, Inc. announced it has initiated a voluntary nationwide recall of one lot of 1% Lidocaine HCI Injection, USP, 10 mg/mL, 20 mL Multiple-dose Fliptop Vial, NDC 0409-4276-01 Lot 25-090-DK (the lot number may be followed by 01 or 02). This action is due to one confirmed customer report of visible particulate, identified in the primary container, in the form of dark red/black particles. The particulate was identified as oxidized stainless steel. Depending on the particle size, if undetected, it could block administration of the drug to the patient, causing a delay in therapy. Impact to the patient would depend on the time it would take to obtain a new vial, the condition being treated and the patient’s status.

BACKGROUND: The recall is being conducted as a precautionary measure. The root cause has not been determined and is under investigation. Hospira informed customers of the issue in a letter dated Sept. 16, 2013. This lot was distributed March 2013 through June 2013.

RECOMMENDATION: Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-866-364-8812 between the hours of 8am to 5pm ET, Monday through Friday, to arrange for the return of the product. Replacement product from other lots is available. 

Metoclopramide Injection And Ondansetron Injection by Hospira: Recall - Glass Strand Particulates Caused By Glass Supplier - 10/2/2013

AUDIENCE: Pharmacy, Patient, Health Professional

ISSUE: Hospira, Inc. announced it initiated a voluntary nationwide recall of one lot of Metoclopramide Injection, USP, 10 mg/2 mL (5 mg/mL)and two lots of Ondansetron Injection, USP, 4 mg/2 mL, (2 mg/mL). This action is due to a confirmed vial defect where glass particulate matter (glass strands) were identified as being affixed to the inside of the vial walls. There is potential for the glass particulates to dislodge into the solution. To date, Hospira has not received reports of any adverse events associated with this issue for these lots.

BACKGROUND: Metoclopramide Injection, USP, 10 mg/2 mL (5 mg/mL), NDC 0409-3414-01, Lot 28-104-DK (the lot number may be followed by a 01), is packaged in a 2 mL single-dose fliptop vial, with an expiration date of October 1, 2014. Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), NDC 0409-4755-03, Lots 29-484-DK and 29-510-DK (the lot numbers may be followed by a 01) are packaged in a 2 mL single-dose fliptop vial, with an expiration date of May 1, 2015. Both products are packaged as 25 units per carton/100 units per case in glass fliptop vials. The affected lots were distributed nationwide between June 2013 and September 2013 to wholesalers/distributors, hospitals and pharmacies. 

The administration of an injectable with the presence of foreign particulates may potentially result in local inflammation, thrombophlebitis, and/or low-level allergic response. Signs and symptoms could include redness, pain, swelling at the site, fever, shortness of breath, tachycardia, nausea and vomiting.  Additionally, the particulate contaminants could potentially act as an emboli and impede blood flow causing tissue/organ damage, especially in vulnerable patients such as those undergoing surgery, immunosuppressed individuals, infants, children and the elderly, as well as patients with micro or macrovascular disease, such as cardiac and renal disease, who may be more at risk since their vasculature, and end organs, are already compromised.  

RECOMMENDATION: Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-877-497-3125 between the hours of 8am to 5pm ET, Monday through Friday, to arrange for the return of the product. Replacement product from other lots is available.