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Home / FDA News Release Reports Voluntary Recall of...

FDA News Release Reports Voluntary Recall of All Ameridose Drug Products

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The U.S. Food and Drug Administration (FDA) announced in a news release that Ameridose, LLC voluntarily recalled all of its unexpired products in circulation.

The FDA’s preliminary finding in an ongoing inspection of Ameridose’s facility has raised flags about a lack of sterility assurance for products produced at and distributed by the facility.  When non-sterile injectable products are used, there is a risk for a serious health hazard.

“The FDA’s top priority is to ensure that drugs are safe for the American public,” said FDA Commissioner Margaret A. Hamburg, M.D.

The inspection of Ameridose’s facility is a part of the FDA’s ongoing investigation on the fungal meningitis outbreak.

In a previous release, the FDA recommended that follow-up with patients be done when the following three conditions are met:

  • The medication was an injectable product purchased from or produced by NECC, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution,
  • The medication was shipped by NECC on or after May 21, 2012, and
  • The medication was administered to patients on or after May 21, 2012.

“Because the preliminary results of the FDA’s inspection raise concerns about the sterility assurance of Ameridose’s products, the FDA is advising health care professionals to stop using all Ameridose products and follow the recall procedures provided by the firm,” explained Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research.

The Centers for Disease Control and Prevention has provided a Multistate Fungal Meningitis Outbreak Investigation website which provides information and updates on the current situation.

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