Due to repeated violations of manufacturing standards the U.S. Food and Drug Administration have seized all medicines produced by generic drug maker Caraco Pharmaceutical Laboratories Ltd.

The FDA ordered U.S. Marshals to seize products from the company’s plants in Detroit, Farmington Hills, and Wixom, Mich. The company manufacturer’s generic drugs which include cardiac, psychiatric and pain medications and the agency said this could lead to shortage of a particular type of pain reliever. The shortage could be of one pain drug, choline magnesium trisalicylate, in particular but it is used by a small percentage of patients.
As many as 33 different drugs may have been seized at the company's three manufacturing plants all located in Michigan as well as drug ingredients were also being held.

During an afternoon teleconference Thursday, Deborah M. Autor, director of FDA's Office of Compliance, Center for Drug Evaluation and Research said, "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."

The FDA's action stops Caraco from distributing drugs until the company provides the agency assurance that it is complying with good manufacturing requirements.

FDA officials advised consumers who are currently on medication made by Caraco that they should not stop, as any drugs that were defective are no longer on the market after a series of recalls since January.  The agency added that the recalls were related to defects such as oversized tablets and possible formulation errors.

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

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

"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.
A Caraco spokesman could not be reached for comment.

"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.

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