Mass. drug company recall raises shortage concerns

FDA: Recall is out of an abundance of caution

 

A sister company to the Massachusetts compounding pharmacy linked to a multistate meningitis outbreak on Tuesday announced a voluntary recall of any products remaining in circulation.

Ameridose, a drug manufacturer and compounder with the same ownership as the New England Compounding Center, said in a statement the move was voluntary "and represents an expansion of our cooperation with the U.S. Food and Drug Administration and the Massachusetts Board of Registration in Pharmacy."

The company said during the FDA's ongoing inspection of its facility, it was notified the FDA would be "seeking improvements in Ameridose's sterility testing process. ... 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."

The inspections come in the wake of the fungal meningitis outbreak that has sickened 377 people and killed 28.

However, federal officials said the recall may contribute to a shortage of products.

"The FDA has identified some Ameridose products that currently appear on the critical shortage list," the agency said in a statement. "These products were in shortage before the Ameridose recall, but supplies may be further affected as a result. ... The FDA is working with alternative manufacturers to maintain supplies of these life-saving drugs."

The Massachusetts Department of Public Health previously had asked Ameridose and another company, Alaunus Pharmaceutical, to cease all pharmacy operations based on their shared ownership and leadership with NECC.

Because the recall is recommended "out of an abundance of caution," the FDA said health care professionals do not need to follow up with patients who received Ameridose products.

"Since its founding in 2006, Ameridose has shipped more than 70 million units of product," said Ameridose spokesman Andrew Paven. "During those six years, Ameridose has maintained an excellent working relationship with its regulatory authorities nationwide and has never been the subject of a lawsuit related to product experience or patient safety. The company agreed to a voluntary recall of all products in circulation because customer confidence is paramount to its business."