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FDA Seizes All Drugs From Generics Maker
Date:6/25/2009

Agency cites poor quality at Michigan plants, warns of potential shortage of one pain reliever

THURSDAY, June 25 (HealthDay News) -- The seizure of all drugs and drug ingredients at a Michigan-based manufacturer by the U.S. Food and Drug Administration could lead to a shortage of a particular type of pain reliever, the agency said on Thursday.

The FDA ordered U.S. Marshals to seize the products from plants run by Caraco Pharmaceutical Laboratories Ltd in Detroit, Farmington Hills, and Wixom, Mich. Caraco manufactures generic drugs, including cardiac, psychiatric and pain medications, the FDA said in a Thursday afternoon press briefing.

"This action follows the company's continued failure to meet the FDA's current Good Manufacturing Practice requirements, which assure the quality of manufactured drugs," Deborah M. Autor, director of FDA's Office of Compliance, Center for Drug Evaluation and Research, said during an afternoon teleconference Thursday.

Caraco makes 33 drugs that may be affected, Autor said. She said that despite the action taken by the agency, consumers should still take any drugs made by Caraco that they may still have.

The seizure may cause a shortage of one pain drug, choline magnesium trisalicylate, in particular. However, the drug is used by only a small percentage of patients and patients can find alternatives by consulting their doctor, Autor said.

The FDA took the action due to Caraco's failure to meet the agency's Good Manufacturing Practice requirements after several warnings, Autor said. The FDA's action stops Caraco from distributing drugs until the company provides the agency assurance that it is complying with good manufacturing requirements.

Starting in January 2009, Caraco voluntarily recalled drugs that the FDA considered defective. The recalls were due to manufacturing defects, including oversized pills and possible errors in the contents of the drugs.

In May, the FDA inspected Caraco once again and found continued violations of good manufacturing practices.

"Caraco exhibited poor control of their raw materials used to make their products," David Jaworski, a consumer safety officer in FDA's Office of Compliance in the Center for Drug Evaluation and Research, said during the teleconference.

"Also we saw that the firm's tablet manufacturing processes had higher than normal variability, which we believe has not adequately been addressed. We have also observed poor decisions being made by the company's management who are responsible for the quality of the drug products being manufactured," he said.

The agency is looking to work with Caraco to correct the problems in its manufacturing process, Autor said.

"Our goal is to get Caraco up and running safely," Autor said. "Seizures often lead to major changes by companies that help them break a cycle of poor performance," she noted.

More information

For more information on recalled Caraco products, visit the U.S. Food and Drug Administration.



SOURCES: June 25, 2009, teleconference with: Deborah M. Autor, director, Office of Compliance, Center for Drug Evaluation and Research; David Jaworski, consumer safety officer, Office of Compliance, Center for Drug Evaluation and Research, both U.S. Food and Drug Administration


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