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U.S. inspection yields another compound pharmacy recall

Source: Thomson Reuters Foundation - Mon, 25 Mar 2013 18:39 GMT
Author: Reuters
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BOSTON, March 25 (Reuters) - The U.S. crackdown on specialty pharmacies that compound drugs into customized doses on Monday yielded another recall after an inspection by the Food and Drug Administration.

Pallimed Solutions Pharmacy, which specializes in treating erectile dysfunction, said it issued a voluntary recall of 16 sterile compound products, including injectable testosterone. Pallimed of Woburn, Massachusetts, also said it agreed to stop all sterile compounding activities.

"The company took this aggressive precautionary recall measure on the basis of information observed during the course of an inspection conducted by the U.S. Food and Drug Administration and the Massachusetts Board of Registration in Pharmacy," Pallimed said in a statement. The recall is limited to sterile compounded products dispensed on or after Jan. 1.

U.S. authorities are coming to grips with how to oversee compounding pharmacies in the wake of a deadly meningitis outbreak that has killed 50 and injured more than 700 people.

FDA Commissioner Margaret Hamburg said in an official blog post on Friday that serious problems continue to take place at compounding pharmacies and she is hopeful that the Senate committee with jurisdiction over the issue "will yield strong legislation for patients across the nation." (Reporting By Tim McLaughlin; Editing by Maureen Bavdek)

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