PRESS RELEASE – FOR IMMEDIATE RELEASE

Published: July 24, 2008

On April 8th 2008, the FDA announced a Class-1 Recall of lots of Bertek and UDL Laboratories Digitek Tablets Manufactured and Distributed by Generic Drug-Maker Actavis and Mylan Pharmaceuticals because tablets may contain up to DOUBLE the dose of the drug Digoxin.

Digitek is a generic brand of the drug Digoxin used to treat heart conditions, including atrial fibrillation, atrial flutter and congestive heart failure. The Plaintiff's allege , consistent with the drug's label, that an overdose of Digitek, or unwittingly taking a dose greater than the dose prescribed by a physician, can cause a host of severe and sometimes life threatening injuries including cardiac, kidney, gastrointestinal and central nervous system injuries, and even death.

A Class Action lawsuit was filed today in the United States District Court for the District of New Jersey. The suit was filed against the drug companies that manufactured and distributed the defective drug on behalf of a nationwide class of patients who were prescribed, and unwittingly ingested, the recalled Digitek. The plaintiffs allege that Actavis Mylan and their subsidiaries negligently and recklessly manufactured, tested, inspected and released a dangerous, misbranded and adulterated drug that contained a dose of digoxin that was higher than the dose on the drug's label.

A Warning Letter was sent to Actavis by the FDA in early 2007 following the inspection of a plant in NJ. In the letter the FDA chastises the generic drug maker for several deviations from good manufacturing practices. The letter is available on the Federal Drug ADministration's Website at the following URL http:www.fda.gov/foiwarningletters/archive/g6235d.htm

The letter catalogues a long list of manufacturing, testing and inspection violations resulting in strength, quality, and purity flaws in many of the drugs including Digitek. The plaintiffs also allege that the drug makers putthe public at further risk by delaying the recall of the misbranded and audulterated Digitek, and then failing to provide the medical community and the public with full, complete, and adequate information about the extent of the danger, including how many, and which lots of Digitek contained amounts of unapproved digoxin; how long the drug-makers were manufacturing and producing the bad drug, how long it was supplied, sold, distributed and released into the stream of commerce and how many "reports of illness and injuries have been received."

For more information on this Class Action Lawsuit and Drug Recall please contact Messa & Associates P.C. today for a consultation.