FDA warns another drugmaker over tainted meds

By Blake Ellis, staff reporter


NEW YORK (CNNMoney.com) -- You may have thought you were playing it safe by avoiding recently-recalled Johnson & Johnson products, but another drugmaker is now in the hot seat for some of the same problems, including the release of metal-tainted pills.

On Thursday, the U.S. Food and Drug Administration issued a warning letter to one of the world's largest manufacturers of generic drugs, Michigan-based Perrigo Co.

The FDA said Perrigo failed to take appropriate action after the FDA cited the drug maker with a number of violations following an inspection of its facilities earlier in the year.

The first violation was issued for releasing products that didn't meet quality control standards, including ibuprofen tablets contaminated with metal shavings from an equipment failure, the FDA said.

"Although your firm segregated a portion of the lot that was affected, you released and shipped a subportion of that segregated lot, resulting in a recall of the entire lot," Joan Givens, director of the FDA's Detroit District Office said in the letter.

The FDA also cited Perrigo for failing to correct and verify label content, for not adequately inspecting its facilities and for failing to thoroughly investigate the possible contamination of some of its products, such as why certain ibuprofen tablets weren't the same size.

While the drugmaker responded to the citations back in February, the response was not adequate, Givens said.

"Your response does not provide the corrective actions your firm plans to take to prevent reoccurrences in the future," she said.

Perrigo has 15 days from the receipt of Thursday's letter to explain to the FDA what steps it has taken to address these violations, the agency said in the letter.

"We are continuing to work with the FDA to ensure corrective actions are in order and approved in all areas of the investigation," said Perrigo spokesman Arthur Shannon.

The FDA's letter comes the same day agency officials testified at a Congressional hearing about Johnson & Johnson's recent series of recalls, one of which also involved possible metal contamination of its children's Tylenol pills.

Despite the FDA's warning,Perrigo (PRGO) still managed to eke out gains in Thursday trading, rising 4% to $60.24, while Johnson & Johnson (JNJ, Fortune 500) fell 0.15% to $59.03. To top of page

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