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FDA Reports Voluntary Recall of All Ameridose Drug Products
By News Staff
According to the FDA, Ameridose is providing a complete list of all products subject to recall (53-page PDF; About PDFs). Products also can be identified by markings indicating the company by name or by its logo.
In conjunction with Massachusetts authorities, the FDA currently is conducting an inspection of the Ameridose facility. Preliminary findings have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility. Most products produced at and distributed by the facility are represented by Ameridose to be sterile products. Ameridose ceased all pharmacy and manufacturing operations on Oct. 10, 2012.
The recall is not based on reports of patients with infections associated with Ameridose products, so at this time, the FDA is not recommending that health care professionals follow up with patients who received Ameridose products, but they should stop using the company's products and return them to the firm.
Health care professionals with Ameridose products on hand should contact the company at (888) 820-0622 to obtain instructions on how to return them.
According to the release, some of the recalled products currently appear on the critical shortage list, and the FDA is working with alternative manufacturers to maintain supplies of these life-saving drugs.
"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," said FDA Commissioner Margaret Hamburg, M.D.
Adverse events that may be related to the use of these products can be reported to MedWatch, the FDA's safety information and adverse event reporting program.