Recall on Valsartan Products Expanded

  • January 3, 2019

    Mylan Laboratories Limited (Mylan) announced on December 4, 2018 that it’s expanding its nationwide, voluntary recall of valsartan products to include all lots within expiry. Mylan issued the recall for these valsartan products due to detection of trace amounts of an impurity, N-nitrosodimethylamine (NDEA), which is classified as a human carcinogen.

    Because valsartan treats serious medical conditions, we’re advising our customers to continue taking their prescription and to contact their provider for further instruction. You don’t need to write a new prescription if you opt to switch your patient to a different manufacturer.

    For more information on the recalled products including product name, catalog number, lot number, and expiration date, visit https://www.fda.gov/Safety/Recalls/ucm627647.htm.

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