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July 2018

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  • Update on Valsartan Recalls: FDA updates both lists of products included in the recall and the list of products NOT included in the recall

    Monday, July 30, 2018
       

    Today, FDA is updating health care professionals and patients after discovering that several additional companies that repackage drug products are also recalling valsartan-containing products.

    FDA has product recall information from three additional repackagers of valsartan-containing products made by Teva Pharmaceuticals and Prinston Pharmaceuticals Inc. – labeled as A-S Medication Solutions LLC, AvKARE and RemedyRepack – and the agency has added them to the recalled products list. Two of these companies, A-S Medication and RemedyRepack, may also distribute valsartan products not affected by the recall. The agency is confirming this information and will provide an update once it is available.

    The following additional repackagers are recalling or are expected to recall valsartan-containing products. FDA is working to gather product recall information from these companies and has removed them from the list of products that are not impacted by this recall:

    • Bryant Ranch Prepack Inc.
    • H. J. Harkins Company Inc. (this company was not originally included on either list)
    • Lake Erie Medical, doing business as Quality Care Products LLC
    • NuCare Pharmaceuticals Inc.
    • Northwind Pharmaceuticals
    • Proficient Rx

    It is possible that not all valsartan-containing products repackaged by these companies are impacted by the recall. FDA continues to evaluate valsartan-containing products and will update the list of products included in the recall and the list of products not included in the recall as more information becomes available.

         

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  • UPDATE: Zoll LifeVest 4000 Wearable Cardioverter Defibrillator - Potential Lack of Treatment (Shock) Delivery Due to Device Failure: FDA Safety Communication

    Wednesday, July 25, 2018

    In January 2018, the FDA issued a Safety Communication alerting patients and health care providers that the LifeVest 4000 may fail to deliver a life-saving shock to a patient if the device is not replaced soon after displaying "Call for service: Device has a problem that may require service. Call Zoll for service, Message Code 102." Failure to contact Zoll immediately and replace the device after Message Code 102 appears on the device screen may result in serious patient harm or death of the patient because the device may fail to deliver treatment if needed. Zoll issued a voluntary recall for the LifeVest 4000 on January 14, 2018 due to the potential for the device to not deliver treatment. Since January, Zoll has updated FDA with information on their plan to address the Message Code 102 issue as follows:

    1. Zoll Patient Service Representatives use the WEAR Checklist during patient fitting and training to reinforce instructions about how to wear the device, when to change the battery, and how to respond to siren alerts and gong alerts. Patients sign the WEAR Checklist and the checklist is returned to Zoll to be kept on file. Zoll updated the WEAR Checklist to include these instructions: “Call Zoll immediately if “Call for Service – Message Code 102” appears on the LifeVest screen. A replacement device will be provided within 24 hours.” The updated WEAR Checklist has been provided with each new LifeVest system shipment since March 21, 2018 as Zoll’s form of patient communication for the recall.
    2. Zoll is planning to implement a software design change for the LifeVest 4000 with a new, more prominent and persistent message scheme for Code 102. The proposed software change needs to be submitted to FDA for review and approval.

    The FDA believes that the updated WEAR Checklist for patients with instructions about how to respond to Message Code 102 will help increase awareness of the potential hazard and increase the likelihood of a patient contacting Zoll immediately for a replacement device after the alert appears on the device screen. The FDA will work expeditiously to review any changes from Zoll that may affect patient safety and will continue to work with Zoll to identify a permanent solution to the Message Code 102 issue.

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  • FDA Updates on Valsartan Recalls

    Wednesday, July 25, 2018
    Investigation ongoing – statement to be updated as more information is available

    FDA publishes a list of valsartan-containing products not part of the recall

    Update [7/24/2018] FDA is updating health care professionals and consumers on the agency’s progress in responding to the ongoing recalls of valsartan, which is used to treat high blood pressure and heart failure, due to the presence of NDMA. The agency has posted a list of valsartan-containing products not impacted by this recall. FDA continues to evaluate valsartan-containing products and will update the list of products included in the recall and the list of products not included in the recall as more information becomes available.

    Manufacturers of these products often produce multiple dosage strengths, however not all of them are being recalled. FDA recommends health care professionals and patients carefully check these lists. Health care professionals and patients should check this statement frequently for any updates.

    FDA reminds consumers to continue taking your current medicine until your doctor or pharmacist gives you a replacement or a different treatment option. Untreated hypertension (high blood pressure) leads to an increase in the risk of heart attacks and stroke. Untreated heart failure increases the risk of hospitalization and death.

    Consumers and health care professionals should continue to report any adverse reactions with valsartan-containing products, to the FDA’s MedWatch program to help the agency better understand the scope of the problem:

    • Complete and submit the report online at www.fda.gov/medwatch/report.htm
    • Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178

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  • Update to FDA Announcement Re Voluntary Recall of Several Medicines Containing Valsartan

    Thursday, July 19, 2018

    This press release was updated on July 17, 2018, to add links to the press releases issued by each company, to include information about supplier of the active ingredient and to update the contact information for consumers.

    The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being recalled. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.

    The FDA’s review is ongoing and has included investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company.

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  • Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

    Monday, July 16, 2018

    Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions.

    Daptomycin for Injection has been associated with reports of adverse events indicative of infusion reactions, including chills, tremor, pyrexia and dyspnea. Other infusion reaction adverse events, that were reported, included events such as tachycardia and blood pressure changes. This recall decision is made out of an abundance of caution for patients while Hospira continues its investigation into the reported infusion reactions.

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  • FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity

    Monday, July 16, 2018

    The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being recalled. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.

    The FDA’s review is ongoing and has included investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company.

    “The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they’re manufactured,” said FDA Commissioner Scott Gottlieb, M.D. “When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market. As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients’ therapeutic needs are met in the United States with an adequate supply of unaffected medications.”

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  • Rising Numbers of Deaths Involving Fentanyl and Fentanyl Analogs, Including Carfentanil, and Increased Usage and Mixing with Non-opioids

    Wednesday, July 11, 2018

    This Health Alert Network (HAN) Update is to alert public health departments, health care professionals, first responders, and medical examiners and coroners to important new developments in the evolving opioid overdose epidemic, which increasingly involves illicitly manufactured fentanyl and an array of potent fentanyl analogs (i.e., compounds that are chemically related to fentanyl). It is the second update to the original health advisory, HAN 384, issued October 26, 2015, which alerted the public to the increase in unintentional overdose fatalities involving fentanyl in multiple states, primarily driven by illicitly manufactured fentanyl. The first update to this health advisory was released on August 25, 2016 (HAN 395), describing the sharp increase in the availability of counterfeit pills containing varying amounts of fentanyl and fentanyl analogs, the continued increase of overdose deaths involving fentanyl across a growing number of states, and the widening array of fentanyl analogs being mixed with heroin or sold as heroin. 

    The current update includes information on: (1) the continued increase in the supply of fentanyl and fentanyl analogs detected by law enforcement; (2) the sharp rise in overdose deaths involving fentanyl and fentanyl analogs in a growing number of states, in particular the growing number of deaths involving the ultra-high potency fentanyl analog known as carfentanil; (3) the expanding number of poly-drug combinations implicated in opioid overdose deaths, which include non-opioids, such as cocaine; (4) the updated comprehensive guidance available to law enforcement and other emergency responders to prevent occupational exposure to fentanyl and fentanyl analogs; and (5) updated recommendations for public health professionals and health care providers regarding prevention and response efforts.

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  • Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects

    Wednesday, July 11, 2018

    Fluoroquinolone antibiotics are approved to treat certain serious bacterial infections, and have been used for more than 30 years. They work by killing or stopping the growth of bacteria that can cause illness. Without treatment, some infections can spread and lead to serious health problems.

    Most fluoroquinolone antibiotic drug labels include a warning that blood sugar disturbances, including high blood sugar and low blood sugar and depending on the fluoroquinolone antibiotic class, a range of mental health side effects are already described under Central Nervous System Effects in the Warnings and Precautions section of the drug label, which differed by individual drug. 

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