Fda Reports Voluntary Recall Of All Ameridose Drug Products

The, United States Food and Drug Administration announces that Westborough

, Massachusetts based Ameridose, LLC is voluntarily recalling all its unexpired products that are in current circulation. The step was taken after the immediate inspection of companys manufacturing site by the FDA. Although the inspections are still going-on, nonetheless, preliminary inspection of the agency had pointed out some deviation from standard operating procedures and standard manufacturing procedures where the federal agency FDAs findings have raised concerns about lack of sterility assurance for products produced at and distributed by this facility.

According to the notification by the United States Food and Drug Administration all these products manufactured and marketed by the company could be identified by markings that indicate Ameridose either by the company logo or by the name of the company.

According to FDA use of non-sterile injectable medical products could lead to serious health complications and hazards and many of them represent life-threatening injuries. Ameridose is supposed to manufacture all the injectable medicinal products keeping the safety of people in mind and that all have to have sterile products. However, recent happenings in the manufacturing units showed an anomaly and it is clear that the company will have to work much more to ensure that their products are sterile and safe to use.

The seriousness of the issue could be acknowledged with the fact that following this inspection Ameridose has entered into a voluntary agreement with the Massachusetts Board of Registration in Pharmacy to cease all pharmacy and manufacturing operations starting on Oct. 10, 2012.

It is important to underline here that Ameridose is a state-licensed, FDA and DEA registered medicinal injectable products manufacturer offering wide range of medical service to health care professionals, pharmacies and hospitals across the United States. The company also offers repackaging, sterile admixing and as well as oral syringes admixing and repackaging services.

However, one thing that should be noted and outlined here is that this recall is not based on reports of patients with infections of Ameridoses products; the recall was made as a precautionary measure to avoid any kind of mishaps that could otherwise happen. Hence, at this point of time the Food and Drug Administration is encouraging and recommending hospitals, health care professionals, and emergency units to stop using these injectable products and if they already have any lot of these products they need to return it to the company.

The complete list of medicines recalled by Ameridose with this notification could be found here.

Any individual or entity like clinics, health care units, hospitals and emergency units already having injectable products from Ameridose should contact to the respective authority at 888-820-0622 to obtain instructions on how to return products to Ameridose.

by: Jack Taylor

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