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FDA seizes two GlaxoSmithKline drugs

March 09, 2005
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According to the Associated Press, GlaxoSmithKline PLC said consumers may see short-term shortages of two types of its drugs, after federal officials seized them from three company facilities Friday, March 4. The Food and Drug Administration found the drug company failed to meet manufacturing standards when producing Paxil CR and Avandamet, and officials seized the drugs from a distribution facility in Knoxville, Tenn., and a manufacturing facility and a distribution facility in Puerto Rico. The FDA did not believe the drugs posed significant health risks to consumers, and did not recommend that patients stop taking them. But the FDA wanted to halt the products'' distribution until the problems are corrected. An FDA inspection found Paxil CR tablets could split apart, potentially leaving patients with portions lacking either the active ingredient or the controlled-release effect. The inspection also found that some Avandamet tablets lacked an accurate dose of one active ingredient. Glaxo recalled certain batches of the two drugs last month, and alerted doctors to the problem. But failure to recall all of the affected product led to the federal seizure, the FDA said.
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