Thursday, November 1, 2012

Huge Drug Recall Latest Fallout in Meningitis Outbreak

By Sharon Begley | November 1, 2012

Ameridose, a sister company of the U.S. pharmacy linked to a meningitis outbreak that has killed 29 people, announced on Wednesday a voluntary recall of all its products, a move to cooperate with regulators that could nevertheless create shortages of some drugs.
In particular, the U.S. Food and Drug Administration and a number of hospitals are concerned about the availability of several drugs for which Ameridose has been a major supplier, including those given as shots or intravenous drips or used during surgery.
The Westborough, Massachusetts-based company, which was closed on Oct. 10, said it had not received any reports of adverse reactions to the products it is recalling but that the FDA has asked it to improve its sterility testing processes.
“Ameridose and FDA agree that the use of injectable products that are not sterile can represent a serious hazard to health,” the company said in a statement, adding that it shipped its medications nationwide.
The company asked its customers to quarantine Ameridose drugs while they arrange to return them to the company.
Earlier in October, the FDA said, “The current production shutdown of Ameridose may impact supplies of certain drugs for some health care systems.”
The FDA “is aware that this recall might affect the availability of certain drugs,” Dr. Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, told Reuters. “This is a company that produces and ships a lot of sterile injectables. We are trying to mitigate the effects (of the Ameridose recall) on drug supplies.”
FILLING THE GAP
The FDA has already spoken with other manufacturers about filling the supply gap left by the shutdown of Ameridose and now the recall of its products, Woodcock said, including helping those whose manufacturing facilities have been curtailed by technical or other issues “get back into production.”
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