Ameridose recalls all drugs after FDA finds problems with its sterility testing

By Chelsea Conaboy, Liz Kowalczyk and Todd Wallack, Globe Staff

Ameridose LLC, sister company to the Framingham pharmacy whose drugs have been implicated in hundreds of fungal infections and 28 deaths, agreed to recall all its products Wednesday after federal investigators identified shortcomings in testing procedures, raising concerns that a shortage of sterile injectable drugs will become more severe.

During the course of its on-going inspection of our facility, the Westborough company said in a press release, the US Food and Drug Administration has notified Ameridose that it will be seeking improvements in Ameridoses sterility testing process.

The company, which supplies thousands of hospitals and other health providers nationally, said it issued the recall voluntarily and had not received any reports of illness.

Neither Ameridose nor the FDA has identified impurities in any Ameridose products, the statement said. 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 FDAs recommendations.

Dr. Janet Woodcock, director of the agencys Center for Drug Evaluation and Research, said that during inspections of Ameridoses production facility, investigators did not find an adequate assurance of sterility in the manufacturing of their sterile products.

In a telephone interview, she said the recall was precautionary and that the agency is not aware of any reports of patient infection.

Woodcock said the agency believes the recall will be large, and is concerned that it will worsen an existing shortage of sterile injectable drugs. She said the FDA is working with other manufacturers to try to help them ramp up production of drugs that could be difficult for hospitals and doctors to find as a result of the recall.

Ameridose shares owners with New England Compounding Center, the Framingham company that prepared steroid injections blamed for the outbreak of meningitis and joint infections around the country. Ameridose had agreed with Massachusetts regulators to suspend operations earlier this month while authorities investigated its operations, but the company has been adamant that allegations against New England Compounding were not reflective of any problems with the sterility of Ameridose products.

The state Department of Public Health said in a statement that to date, its joint investigation with the FDA has found no evidence of contaminated products made by Ameridose. It said the companys agreement to suspend operations, which expires Monday, is under review.

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Ameridose recalls all drugs after FDA finds problems with its sterility testing