FDA Drug Safety Podcast: Ameridose
[11-13-2012] This is an FDA drug safety alert from the Division of Drug Information.
Ameridose, LLC, based in Westborough, Mass., is voluntarily recalling all of its unexpired products in circulation and has agreed to temporarily cease all pharmacy and manufacturing operations. The FDA and State of Massachusetts began inspecting the Ameridose facility as part of the agency’s ongoing fungal meningitis outbreak investigation. Ameridose shares common management by the same parties as New England Compounding Center (NECC). Although this inspection is ongoing, the FDA’s preliminary findings have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility.
FDA recommended this recall out of an abundance of caution. Unlike the NECC recall, the Ameridose recall is not based on reports of infections associated with company product. Thus, FDA recommends that healthcare professionals should stop using Ameridose products but do not need to follow up with patients who received the products.
Healthcare professionals should also isolate all products and contact Ameridose for return instructions. Ameridose products may be identified by markings that indicate Ameridose by name or by its company logo. A complete list of all products subject to this recall is available at www.ameridose.com.
FDA has identified six Ameridose products on the FDA shortage list, which already were in shortage prior to the recall but for which supply shortages may be exacerbated by the recall. You can find the full list at http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm324842.htm. FDA is committed to do everything we can to address any drug shortage, using all available tools.
Please report any suspected adverse events following use of these products to FDA's MedWatch program at www.fda.gov/medwatch.
You may also call the FDA’s Drug Information Line at 855-543-DRUG and press * to get the most recent information and speak directly to a pharmacist.