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Alerts and Recalls

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  • inezolid Injection by Auromedics Pharma: Voluntary Recall

    Thursday, December 28, 2017
    AuroMedics Pharma is voluntarily recalling one lot of Linezolid Injection 600mg/300mL flexible bags, NDC 55150 -242 -51 batch CLZ160007 expiration August 2018 to the hospital level. This batch was distributed May 15 through August 14, 2017. The product was found to contain white particulate matter...

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

    Wednesday, December 20, 2017
    The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.Physio-Control Inc. is recalling infant/child defibrillation electrodes because the artwork on the pads within the packaging shows incorrect placement...

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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...

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  • AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Pantoprazole Sodium for Injection 40 Mg Per Vial

    Wednesday, December 20, 2017
    East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial, to the hospital level. The product was found to contain glass particles in the vial. This problem was discovered as a result of a product complaint in which the...

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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...

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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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