Reuters: Regulatory News: UPDATE 1-Firm linked to US meningitis outbreak recalls all drugs

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UPDATE 1-Firm linked to US meningitis outbreak recalls all drugs Oct 31st 2012, 19:32 Wed Oct 31, 2012 3:32pm EDT BOSTON Oct 31 (Reuters) - Ameridose, a sister company of the U.S. pharmacy linked to a meningitis outbreak that has killed 28 people, announced 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 Food and Drug Administration is concerned about the availability of several drugs given as shots or intravenous drips or used during surgery. The Westborough, Massachusetts-based company said it had not received any reports of adverse reactions to the products it is recalling but that the U.S. Food and Drug Administration 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 this month 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." The FDA has already spoken with other manufacturers about filling the supply gap left by the ongoing shut-down 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." Ameridose has been a major manufacturer of sodium bicarbonate injections, for instance, which are used in emergency care to normalize the acidity of a patient's blood; It also produced succinylcholine, a neuromuscular paralyzing agent used by anesthesiologists during surgery. Hospitals could face shortages of both drugs, Woodcock said. Ameridose is owned by the same people who own the compounding pharmacy that produced injectable steroid shots which turned out to be contaminated with fungus and are blamed for the hundreds of meningitis cases. It was closed on Oct. 10, and since then FDA inspectors have been combing through the production facilities. Link this Share this Digg this Email Reprints

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