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Feds Seize Two Glaxo Drugs

Federal officials seized two types of drugs Friday from a Knoxville, Tenn., distribution center of GlaxoSmithKline PLC after the Food and Drug Administration found the drug company failed to meet manufacturing standards.

Similar seizures of Paxil CR and Avandamet tablets were also made at a manufacturing facility and a distribution facility in Puerto Rico.

Paxil CR is designed to treat depression and panic disorder. Avandamet treats Type II diabetes.

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.

"Split tablets can happen. It's just the nature of the manufacturing," Glaxo spokeswoman Nancy Pekarek told CBS Radio News.

The inspection also found that some Avandamet tablets lacked an accurate dose of one active ingredient.

"A very small number of Avandament tablets might have a slightly raised level of the active ingredient, which is called rosiglitazon," said Pekarek. "We believe we've identified a problem in the process that we are currently correcting."

The company also instituted a full inspection of Paxil CR, said Pekarek. But she said it was not clear when the issues would be resolved.

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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