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