Company With Links to Meningitis-Linked Pharmacy Recalls All Products

FDA finds worrisome conditions at Ameridose plant, which has same owners as New England Compounding Center

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By Steven Reinberg and Margaret Steele
HealthDay Reporters

WEDNESDAY, Oct. 31 (HealthDay News) -- A firm with the same founders as New England Compounding Center, the pharmacy linked to the deadly meningitis outbreak, announced Wednesday that it would voluntarily recall all of its products.

"Ameridose LLC, based in Westborough, Mass., is voluntarily recalling all of its unexpired products in circulation," the U.S. Food and Drug Administration said in a statement.

"The FDA is currently conducting an inspection of Ameridose's facility," the agency added. "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."

While the FDA stressed that there have so far been no reports of infections linked to Ameridose products, they say they recommended the recall "out of an abundance of caution."

"Health care professionals and patients may dial the FDA's Drug Information Line at 855-543-DRUG [3784] and press [the star sign] to get the most recent information regarding the Ameridose recall and speak directly to a pharmacist," the agency added.

In the meantime, the death toll from the ongoing fungal meningitis outbreak rose to 29 on Wednesday, with 377 illnesses reported across 19 states.

The newest fatality occurred in Virginia, according to the latest daily tally issued by the U.S. Centers for Disease Control and Prevention.

The recall follows news last week of unsanitary conditions at the Framingham, Mass.-based New England Compounding Center plant. On Friday, federal investigators said their tour of the plant found foreign, "greenish-black" material in some vials of the injectable steroid suspected as the cause of the illnesses.

The contaminated product was one of a host of potential violations discovered during a recent inspection of New England Compounding Center's plant, FDA officials said during a Friday press briefing.

"The investigators observed approximately 100 vials of the steroid drug, which purports to be a sterile injectable drug, that had a greenish-black foreign material and a white filamentous [containing filaments] material inside," Steven Lynn, director of the FDA's Office of Manufacturing and Product Quality, said during the briefing.

The FDA also found the company was not able to keep its "clean room" clean, Lynn said. "A clean room is a space designed to maintain a controlled environment with low levels of airborne particles and surface contamination," he explained.

Over the weekend, Massachusetts officials closed a second compounding pharmacy after inspection revealed conditions that might threaten the sterility of its products.

According to The New York Times, Waltham, Mass.-based Infusion Resource voluntarily surrendered its license over the weekend after inspectors found "significant issues with the environment in which medications were being compounded," Dr. Madeleine Biondolillo, director of the Bureau of Health Care Safety and Quality at the Massachusetts Public Health Department, said at a press briefing.

While she did not release details of what the inspection found, Biondolillo did say that patients had been receiving intravenous medications at the pharmacy, violating state law.

Massachusetts officials said last Tuesday that they had begun a criminal investigation into New England Compounding Center. They added that the company functioned as a drug manufacturer, producing drugs for broad use, rather than filling individual prescriptions for individual doctors, in violation of its state license, CBS News reported.

According to published reports, state records show that the New England Compounding Center was plagued by problems as far back as 2006. Those records, obtained by the Associated Press under a public documents request, showed there was evidence of inadequate contamination control and no written standard operating procedures for using equipment, among other problems, at the facility.

New England Compounding Center and Infusion Resource are both compounding pharmacies. These pharmacies combine, mix or alter ingredients to create drugs to meet the specific needs of individual patients, according to the FDA. Such customized drugs are frequently required to fill special needs, such as a smaller dose, or the removal of an ingredient that might trigger an allergy in a patient.