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HSAG ESRD Alerts, Recalls, and Notices

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  • Clopidogrel Tablets USP, 75 mg by International Laboratories: Recall

    Friday, January 12, 2018

    International Laboratories, LLC is voluntarily recalling Lot# 117099A of Clopidogrel Tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Clopidogrel Tablets USP, 75 mg but may contain Clopidogrel 75mg or Simvastatin Tablets USP 10 mg.

    Missed doses of Clopidogrel increases the risk of heart attack and stroke which can be life threatening.

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  • Physio-Control Inc. Recalls Defibrillation Electrodes Due to Incorrect Placement Instructions for Infants Depicted on Artwork

    Wednesday, December 20, 2017

    Physio-Control Inc. is recalling infant/child defibrillation electrodes because the artwork on the pads within the packaging shows incorrect placement instructions for infants. There is no issue with the performance or function of the defibrillation electrodes. However, incorrect placement of the electrodes on an infant may result in failure to deliver an effective shock to an infant in cardiac arrest. A delay in therapy could result in serious injury and/or death.

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  • Gadolinium-based Contrast Agents (GBCAs): Drug Safety Communication - Retained in Body; New Class Warnings

    Wednesday, December 20, 2017

     FDA is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs. Gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and FDA has concluded that the benefit of all approved GBCAs continues to outweigh any potential risks.

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  • Albumin Human 25 Percent Solution (AlbuRx 25): Product Information Advisory - Fading Print On Label

    Monday, December 4, 2017

    During routine inspection of retained AlbuRx 25% samples CSL Behring noted the potential for fading print with more effect on the expiration dating on the patient tear off portion of the vial label. This is limited to 50 and 100 mL vial sizes. CSL Behring is taking no action with products on the market but is addressing the print settings to ensure readability throughout the shelf life of the product. If the lot number and expiration dating is not able to be verified, customers are asked to contact CSL Customer Support.

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  • The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication

    Wednesday, November 29, 2017
    The FDA is alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected.

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  • Riomet (Metformin Hydrochloride Oral Solution): Recall - Microbial Contamination

    Tuesday, November 28, 2017

     

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  • FDA Alerts Consumers About Potentially Life-Threatening Health Problems Linked to Limbrel

    Monday, November 27, 2017
    The U.S. Food and Drug Administration is investigating serious adverse events involving Limbrel, a product in capsule form currently being marketed as a medical food to manage the metabolic processes associated with osteoarthritis.

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  • FDA Statement: Impact of IV Fluid Shortages Following Hurricane Destruction

    Monday, November 20, 2017
    Update on the efforts by the FDA to address IV fluid shortages exacerbated by Hurricane Maria and advice for hospitals in managing the shortage

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  • Baxter Issues A Voluntary Nationwide Recall For One Lot of Nexterone Injection Due To Presence Of Particulate Matter

    Thursday, November 16, 2017
    Baxter International Inc. announced today it is voluntarily recalling one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection – distributed between 8/23/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities – due to the potential presence of...

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  • Febuxostat (Brand Name Uloric): Drug Safety Communication - FDA to Evaluate Increased Risk of Heart-related Death

    Thursday, November 16, 2017
    FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. FDA required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety...

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