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HSAG ESRD Alerts, Recalls, and Notices

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  • Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19--UPDATED

    Wednesday, February 10, 2021
    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds])...

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  • Xeljanz, Xeljanz XR (tofacitinib): Drug Safety Communication - Initial Safety Trial Results Find Increased Risk of Serious Heart-related Problems and Cancer with Arthritis and Ulcerative Colitis Medicine

    Friday, February 5, 2021
    The FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) compared to another type of medicine called tumor necrosis...

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  • Apotex Corp. Issues Voluntary Nationwide Recall of Enoxaparin Sodium Injection, USP Due to Mislabeling of Syringe Barrel Measurement Markings

    Thursday, February 4, 2021
    Apotex Corp is voluntarily recalling two (2) batches of Enoxaparin Sodium Injection, USP to consumer level due to a packaging error resulting in some syringes barrels containing 150 mg/mL markings (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL...

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  • Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers

    Friday, January 29, 2021
    As part of the U.S. Food and Drug Administration’s continuing efforts to protect consumers from potentially dangerous or subpotent hand sanitizers, the agency has placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert to help stop products that appear to be in...

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  • Nostrum Laboratories, Inc. Expands Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

    Wednesday, January 27, 2021
    Kansas City, Missouri,Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets)...

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  • Genetic Variants of SARS-CoV-2 May Lead to False Negative Results with Molecular Tests for Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff and Health Care Providers

    Tuesday, January 12, 2021
    The SARS-CoV-2 virus can mutate over time, resulting in genetic variation in the population of circulating viral strains. The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that false negative results may occur with any molecular test for the...

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  • Fresenius Kabi Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter

    Tuesday, January 12, 2021
    Fresenius Kabi USA is voluntarily recalling a single lot of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter. Particulate matter was found in reserve sample vials. No adverse event reports have been received...

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  • Essaar Inc. Issues Voluntary Nationwide Recall of Rubbing Alcohol Contaminated with Methanol

    Tuesday, January 12, 2021
    Essaar Inc. is voluntarily recalling lot 200528303 of Soho Fresh 70% Rubbing Alcohol in 33.81 oz. clear plastic bottles to the consumer level. FDA analysis of the product revealed it is contaminated with methanol.

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  • Precision Dose, Inc. Issues Voluntary Nationwide Recall of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Due to Microbial Contamination

    Tuesday, January 12, 2021
    Precision Dose, Inc. is voluntarily recalling all lots of Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Unit Dose Cups bearing an expiration date from 1/31/2021 – 02/28/2022 (see specific lots below) to the consumer level. Precision Dose, Inc. was notified by the manufacturer of the...

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  • Nostrum Laboratories, Inc. Expands Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets

    Tuesday, January 12, 2021
    Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) have been found to...

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