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November 2017

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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
    Sun Pharmaceutical Industries is recalling two lots of Riomet (Metformin Hydrochloride Oral Solution), which were found to be contaminated with Scopulariopsis brevicaulis. Use of the affected Riomet potentially could result in a risk of infection, especially in the immunocompromised patient. The...

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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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  • Midazolam Injection, USP, 2 mg/2 mL by Fresenius Kabi: Recall

    Monday, November 6, 2017
    Fresenius Kabi USA is voluntarily recalling Lot of Midazolam Injection, USP, 2 mg/2 mL packaged in a 2 mL prefilled single-use glass syringe to the hospital/user level. The product mislabeled as Midazolam Injection, USP, 2 mg/2 mL contains syringes containing and labeled as Ondansetron Injection,...

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