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Drug recalls surge August 16, 2010

Posted by Dreamhealer in Big Pharma.
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Recalls of prescription and over the counter drugs are surging, raising questions about the quality of drug manufacturing in the United States. The Food and Drug Administration reported more than 1,742 recalls last year, skyrocketing from 426 in 2008, according to the Gold Sheet, a trade publication on drug quality that analyzes FDA data.

One company, drug repackager Advantage Dose, accounted for more than 1,000 of those recalls. Even excluding Advantage Dose, which has shut down, recalls jumped 50% last year.

“We’ve seen a trend where the last four years are among the top five for the most number of drug recalls since we began tallying recalls in 1988,” said Bowman Cox, managing editor of the Gold Sheet. “That’s a meaningful development.”

The fast pace of drug recalls seems to be continuing in 2010. Drug recalls totaled 296 from January through June of this year, said Cox. “If we continue at this same rate, we could get 600 or more recalls by the end of the year,” he said. “That’s still a very high rate of recalls.”

High-profile recalls of Tylenol and other products by McNeil Consumer Healthcare, a unit of Johnson & Johnson (JNJ, Fortune 500), have drawn attention to quality concerns in manufacturing.

The mounting problems over recalls have also drawn attention from lawmakers. Two bills introduced this year would impose stricter regulations on the industry and give the FDA authority to mandate recalls.

The spike in recalls, especially of generic and over-the-counter drugs, is being driven by manufacturing lapses, experts say. Some of the biggest culprits: the quality of raw materials, faulty labeling and packaging and contamination.

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