[11-12-2012] FDA released a copy of a FDA Form 483 issued to Ameridose LLC of Westborough, Massachusetts.
[10-31-2012] The U.S. Food and Drug Administration announced today that Ameridose, LLC, based in Westborough, Mass., is voluntarily recalling all of its unexpired products in circulation. A recent FDA inspection has raised concerns about a lack of sterility assurance for products produced at and distributed by Ameridose. Products from Ameridose can be identified by markings that indicate Ameridose by name or by its company logo. A complete list of all products subject to this recall can be accessed at www.ameridose.com.
The FDA is advising health care professionals to stop using all Ameridose products and follow the recall procedures provided by the firm. Hospitals, clinics, health care professionals, and other customers with Ameridose products on hand should contact Ameridose at 888-820-0622 to obtain instructions on how to return products to Ameridose.
Health care professionals and patients may call the FDA's Drug Information Line at 855-543-DRUG (3784) and press * to get the most recent information regarding the Ameridose recall and speak directly to a pharmacist.
The FDA asks health care professionals and consumers to report any adverse reactions to the FDA's MedWatch Program by fax at 800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.