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31-10-2012 | Article

Second Mass pharmacy recalls all products

Abstract

FDA

medwireNews: Ameridose LLC, a Massachusetts pharmacy owned and operated by the team that runs the compounding pharmacy at the center of the fungal meningitis outbreak, is voluntarily recalling all of its unexpired products in circulation.

"During the course of its on-going inspection of our facility, FDA [Food and Drug Administration] has notified Ameridose that it will be seeking improvements in Ameridose's sterility testing process," the company said in a "Dear Customer" letter.

"Ameridose and FDA agree that the use of injectible products that are not sterile can represent a serious hazard to health and could lead to life-threatening injuries and/or death. Ameridose has not received any adverse reports related to the products subject to this recall and neither Ameridose nor the FDA has identified impurities in any Ameridose products. Nevertheless, out of an abundance of caution, we are undertaking this recall to assure customers that when Ameridose products are shipped, they are fully in conformance with all of the FDA's recommendations.," the letter says.

Ameridose, based in Westborough, Massachusetts, is a "sister" pharmacy to the New England Compounding Center (NECC) in Framingham, Massachusetts, which has been linked to the nationwide fungal meningitis outbreak.

"The FDA is advising health care professionals to stop using all Ameridose products and follow the recall procedures provided by the firm," the FDA said in a statement.

As of October 31, 377 fungal meningitis cases and 28 deaths have been reported in 19 states, according to the Centers for Disease Control and Prevention.

The outbreak has been traced to three contaminated lots of methylprednisolone acetate and possibly other products produced by NECC. FDA inspectors found sealed vials of product containing visible greenish-black foreign matter at the pharmacy. The Commonwealth of Massachusetts is seeking to permanently revoke the pharmacy licenses of the company and the pharmacists who compounded the tainted drugs.

The Boston Globe reports that NECC internal tests found contamination throughout its laboratories. But the company still sent customers a "Quality Assurance Report Card" claiming that the facility met cleanliness standards.

A sample taken by NECC consisting of one 5 ml vial of bulk formulated methylprednisolone acetate tested sterile, but an FDA analysis of further samples confirmed the presence of viable microbial growth in each of 50 vials tested, the agency reports.

By Neil Osterweil, medwireNews Reporter