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Digitek Recall April 2008

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The Digitek recall that was announced on April 25, 2008 covers all of the tablet-form Digitek on the market in the U.S. All dosage levels of the tablets were voluntarily recalled by the manufacturer of Digitek, Actavis Totowa LLC, based in Morristown, New Jersey.

Because it contains twice the dose of active ingredient, the recalled Digitek can cause serious, potentially life-threatening side effects such as cardiac arrhythmia and bradycardia.

The Digitek recall did not involve the fluid-filled capsules, elixir, and intravenous/intramuscular injection forms of the drug.

Before the Digitek Recall
In July 2006, August 2006, and February 2007, the U.S. Food and Drug Administration (FDA) sent warnings to Actavis stating that some of the drugs being produced by the company were not "the identity, strength, quality and purity they purport to possess."

Critics have alleged that Actavis did not respond appropriately to the FDA’s warnings. On April 25, 2008, the FDA announced a Class I, nationwide recall of all strengths of Digitek tablets. A “Class I” recall indicates that the FDA deems the product capable of causing serious injury or death. It is the most serious type of recall issued by the FDA.

The FDA provided a number at which people can report any adverse reactions to Digitek: 800-332-1088 (the FDA's MedWatch Program). At the time of the Digitek recall, the FDA had already received several reports of illnesses and medical events related to Digitek treatment.

Lawsuits Follow the Digitek Recall
The Digitek recall was eventually followed by many lawsuits against Actavis and the two companies that distribute Digitek in the U.S., Mylan Pharmaceuticals and UDL Laboratories. Some of these lawsuits allege that the Digitek recall would not have been necessary if Actavis had adequately responded to earlier warnings from the FDA about the quality of the Digitek being produced.

Get More Information about the Digitek Recall
If Digitek treatment has harmed you or someone you know, contact a defective drugs attorney today to learn more about your legal options. You may be entitled to compensation for the damages you or your loved one has suffered.

Contact a Digitek Recall Lawyer

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