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FDA Reports Voluntary Recall of All Ameridose Drug Products
The FDA has announced that Ameridose, LLC, based in Westborough, Massachusetts, is voluntarily recalling all of its unexpired products in circulation. 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 currently conducting an inspection of Ameridose’s facility. 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.
The use of nonsterile injectable products can represent a serious hazard to health that could lead to life-threatening injuries, the agency said. Most products produced at and distributed by this facility are represented by Ameridose to be sterile products. Ameridose 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.
This recall is not based on reports of patients with infections associated with any of Ameridose’s products, and the agency recommended the recall as a precautionary measure. Therefore, at this time, the FDA is also recommending that healthcare professionals do not need to follow up with patients who received Ameridose products. However, healthcare professionals should stop using Ameridose products at this time, and return them to the firm.
Hospitals, clinics, healthcare 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 the company.
Together with the State of Massachusetts, the FDA began 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 New England Compounding Center (NECC) of Framingham, Mass. — the firm associated with compounded drugs linked to the ongoing fungal meningitis outbreak.
Source: FDA, October 31, 2012.