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All Ameridose Drug Products Recalled, FDA Reports
FDA announced that Ameridose, LLC, voluntarily recalled all of its unexpired drug products on October 31, 2012. Ameridose, based in Westborough, MA, initiated the recall in response to findings from an FDA inspection that raised concerns about lack of sterility assurance for products at and distributed by this facility. FDA indicates that the company’s products can be identified by markings that indicate Ameridose by name or by its company logo. A complete list (PDF) of all products subject to this recall is available on the Ameridose Web site, as well as an image of the logo.
Together with the state of Massachusetts, FDA commenced the current inspection of the Ameridose facility as part of the agency’s ongoing fungal meningitis outbreak investigation. Ameridose is a company sharing common management by the same parties as NECC of Framingham, MA. FDA continues to inspect the facility, and Ameridose also entered into a voluntary agreement with the Massachusetts Board of Registration in Pharmacy to cease all pharmacy and manufacturing operations starting on October 10, 2012. FDA explains that the recall is not based on reports of patients with infections associated with any of Ameridose’s products, and that the agency recommended this recall out of an abundance of caution. Thus, the agency is not recommending that health care providers follow up with patients who received Ameridose products, but that they should stop using Ameridose products at this time, and return them to the firm. Hospitals, clinics, health care providers, 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 providers and patients may call FDA’s Drug Information Line at 855/543-3784 and press * to get the most recent information regarding the Ameridose recall and to speak directly to a pharmacist. Any related adverse reactions may be reported to FDA’s MedWatch Program by completing the online reporting form or by following the instructions on the FDA Web site in order to fax or mail a report.
