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Voluntary recall of all Ameridose medical products
  • Published Date:
    11/1/12
  • Source:
    HAN ; 332
  • Language:
    English
Filetype[PDF-857.04 KB]


Details:
  • Corporate Authors:
    Centers for Disease Control and Prevention (U.S.) ; United States. Food and Drug Administration. ;
  • Series:
  • Description:
    November 1, 2012, 16:15 ET (4:15 PM ET)

    CDCHAN-00332-2012-01-11-ADV-N

    Voluntary recall of all Ameridose medical products Summary: On October 31, 2012, the Food and Drug Administration (FDA) announced that Ameridose is voluntarily recalling all of its unexpired medical products in circulation. Ameridose is based in Westborough, Mass., and is managed by some of the same people as the New England Compounding Center (NECC), the firm that distributed and recalled injectable medications implicated in the ongoing multistate outbreak of fungal meningitis and other infections. FDA is not aware of any recent reports of infections associated with the recalled Ameridose products. However, the preliminary results of FDA's ongoing inspection of Ameridose have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility. As a result of FD A’s preliminary findings, Ameridose has agreed to voluntarily recall all of its unexpired products in circulation.

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