June 25, 2009 / 8:33 PM / in 10 years

UPDATE 2-US seizes Caraco drugs over manufacturing problems

* Generic medicines seized at Michigan plants

* FDA: Company had repeated manufacturing violations

* Caraco shares drop 43 percent (Recasts; Adds FDA comments)

By Lisa Richwine

WASHINGTON, June 25 (Reuters) - U.S. authorities have seized all medicines produced by generic drugmaker Caraco Pharmaceutical Laboratories Ltd CPD.A following repeated violations of manufacturing standards, health officials said.

The drugs included generic versions of heart, pain and psychiatric medicines, Food and Drug Administration officials said on Thursday. Up to 33 different drugs may have been seized at the company’s three manufacturing plants, all located in Michigan. Drug ingredients also were being held.

After the news, Caraco shares fell 43 percent to $2.39 on the American Stock Exchange.

“This action follows Caraco’s continued failure to meet” manufacturing standards that assure drug quality, an FDA statement said.

“Through this seizure, the FDA seeks to immediately stop the firm from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements.”

A Caraco spokesman could not immediately be reached for comment.

Consumers now taking medicines made by Caraco should not stop, FDA officials advised. Any defective drugs have come off the market in a series of recalls since January. Those recalls were related to defects such as oversized tablets and possible formulation errors, the agency said.

The company was warned about manufacturing problems in an FDA letter sent in October 2008, said FDA consumer safety officer David Jaworski. A May 2009 inspection found unresolved violations.

FDA inspectors found poor control of raw materials, higher- than-normal variability in tablet manufacturing processes and “poor decisions made by the company’s management who are responsible for the quality of drugs being manufactured,” Jaworski said.

The FDA said the seizure may create a shortage of one pain reliever, choline magnesium trisalicylate oral tablets. Patients should talk to their doctors about alternatives if supplies run short, agency officials advised. (Reporting by Lisa Richwine; editing by Steve Orlofsky and Andre Grenon)

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