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Voluntary Recall of All Ameridose Drug Products

November 06, 2012 06:00pm  
Voluntary Recall of All Ameridose Drug Products

The Food and Drug Administration has recently announced that Ameridose, LLC, has voluntarily recalled all of its products that are currently in circulation.  All of the recalled products are magnesium sulfate products.  

The FDA is currently inspecting Ameridose’s main facility in Westborough, Massachusetts.  During the preliminary inspections, the FDA became concerned because there was a lack of sterility as the products were being produced and distributed.  The majority of the recalled products were injectable medications, and the FDA states that unsterile injectables can pose a serious health hazard to patients and even lead to life-threatening injuries.  

No infections have been reported in association with Ameridose products, but the FDA recommended the recall as a precautionary step.  The FDA reports that health care professionals do not need to examine patients who received an Ameridose product at this time.  Health care professionals should stop using unexpired products immediately and return the products to Ameridose.  

The FDA warns that some of the products were on the critical shortage list.  Thus, the voluntary recall will impact the shortage even more.  Commissioner Margaret A. Hamburg, M.D., states, “The agency is taking all steps within its authority to help prevent or alleviate shortage situations and to minimize the impact this recall may have on drug supplies.”  

The inspection of Ameridose products was an extension of an investigation into the fungal meningitis outbreak.  The FDA reports that Ameridose shares management with the New England Compounding Center (NECC)—a firm that was tied to the outbreak of fungal meningitis.  

Health care professionals and patients can call the FDA’s Drug Information Line at 855-543-DRUG to get updated information on the recall and speak to a pharmacist.  Information about the recall and a list of all recalled products is listed on Ameridose’s website.  

Source: U.S. Food and Drug Administration


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