FDA And U.S. Marshals Seize Drug Products From Caraco’s Three Michigan Facilities Due To Continuing Lack Of Quality Controls

(Posted by Tom Lamb at DrugInjuryWatch.com)

On June 25, 2009 the FDA issued a press release, "U.S. Marshals Seize Drug Products Manufactured by Caraco Pharmaceutical Laboratories Ltd. — FDA acts to prevent repeated drug quality problems", which began as follows:

U.S. Marshals, at the request of the Food and Drug Administration, today seized drug products manufactured by Caraco Pharmaceutical Laboratories Ltd. (Caraco), at the company’s Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure also includes ingredients held at these same facilities….

This action follows Caraco’s continued failure to meet the FDA’s current Good Manufacturing Practice (cGMP) requirements, which assure the quality of manufactured drugs. 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.

Since January 2009, Caraco has initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets and possible formulation error.

On March 31, 2009 Caraco recalled its digoxin pills due to the possibility that some of those pills might be oversized and contain too much active ingredient.  Because digoxin is known to have a narrow therapeutic index, it is possible that oversized Caraco digoxin pills caused digitalis toxicity, or digoxin poisoning, in patients using that product.

Earlier, the FDA issued a warning letter to Caraco in October 2008 after FDA inspectors had discovered failures to conform to current Good Manufacturing Practices (cGMP) at some of the companies facilities.

The FDA has provided a list of the 33 Caraco drugs that may be affected by the June 25, 2009 seizure at the company's three Michigan plants.