Recalled Digoxin Manufacturer Raided by US Marshalls and FDA

At the request of the FDA, U.S. Marshals raided generic drug manufacturer Caraco Pharmaceutical Laboratories, Ltd., shutting down manufacturing and seizing inventory. The action came after FDA inspections found that the drug maker was continuing to fail to meet federal safety and health requirements.

In March 2009, Caraco recalled digoxin, a heart medication that requires exact dosage, after it was discovered that some tablets distributed were thicker or thinner than they were supposed to be. This created a serious risk for consumers, as receiving too much of the drug could cause a potentially life-threatening condition known as digoxin toxicity, and receiving too little of the medication could result in injury from the underlying heart condition.

A similar manufacturing problem with Actavis Totowa in April 2008, which led to a recall of Digitek brand digoxin, was linked to 667 deaths according to FDA adverse event reports during the months following the discovery that some oversized tablets were commercially released.

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Caraco received an FDA warning letter in October 2008, but the FDA identified continuing failure to meet the current Good Manufactring Practice (cGMP) requirements during a follow up inspection completed in May 2009.

“Today’s seizure is intended to lead to major changes at Caraco’s facilities,” said the FDA in a statement issued June 25, 2009. “If the FDA identifies further significant problems, which pose risks to patient safety with any Caraco drug products on the market, the agency will take appropriate regulatory action and immediately notify the public.”

The Caraco raid will affect the company’s production of 33 different drugs, including pain, heart, high blood pressure and psychotropic medications. The FDA has said the company will not be allowed to ship any more medication until its facilities meet cGMP requirements. The raids were conducted by federal marshals on the company’s plants throughout Michigan, including facilities in Detroit, Farmington Hills, and Wixom.

Although other companies also manufacture most of the drugs seized, the FDA said the raid might cause a shortage of choline magnesium trisalicylate, a pain killer. Consumers and health care providers should seek alternatives or contact the FDA’s drug shortage program.

Despite the seizure, the FDA said consumers should continue to use any Caraco medications they have already had filled. Agency officials say that they believe that any defective medications have already been recalled, but they find any other problems with Caraco medications currently on the market, they will notify consumers immediately.


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