The death toll has climbed to 28 and the number of sickened patients to 377 in the fungal meningitis outbreak centered on the now-shuttered New England Compounding Center. Now NECC's sister company, Ameridose, is working with the FDA to voluntarily recall all of its unexpired products still in circulation. Healthcare facilities aren't being asked to contact patients on whom Ameridose products were used, but the recall will be a huge blow to the supply of drugs currently on the critical shortage list.

"Because the preliminary results of the FDA's inspection raise concerns about the sterility assurance of Ameridose's products, the FDA is advising healthcare professionals to stop using all Ameridose products and follow the recall procedures provided by the firm," says Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research.

Ameridose has not received any adverse reports related to the products it is recalling, and neither Ameridose nor the FDA has identified impurities in any of the products, according to a company press release. "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," says the company, which issued a recall submission form with the release.

The FDA has identified some Ameridose products that currently appear on the critical shortage list. These products were in short supply before the recall, but may be more scarce as a result of it. The FDA is working with alternative manufacturers to maintain supplies of these life-saving drugs. "The agency is taking all steps within its authority to help prevent or alleviate shortage situations and to minimize the impact this recall may have on drug supplies," said FDA Commissioner Margaret A. Hamburg, MD.

The agency is working with Massachusetts health officials to investigate the Ameridose facility in Westborough, Mass., as part of the agency's ongoing fungal meningitis outbreak investigation. Ameridose shares common management with Framingham, Mass.-based NECC.

Stephanie Wasek