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Caraco Recalls Generic Pills Over Irregular Sizes

-Bloomberg

04/01/2009 - Caraco Pharmaceutical Laboratories Ltd. recalled generic heart tablets that may contain the wrong amount of medicine, sending the drugmaker down the most in four months in New York trading.

The voluntary recall covers 0.125 milligram and 0.25 milligram digoxin tablets distributed before today and within the expiration date of September 2011, according to statements released today by the company and the U.S. Food and Drug Administration. Size differences among the pills may mean they have too much or too little of the active ingredient.

Caraco’s voluntary recall follows a similar move by Actavis Group hf almost a year ago over concerns that some of its generic digoxin tablets may be twice as thick as intended. The medicine has a narrow margin between recommended and lethal doses, and errors in pill size may lead to heart instability, serious side effects or death, especially in patients with kidney failure.

The company and the FDA didn’t say whether anyone has been harmed by the Caraco products. The agency said last year that it received “several reports of illnesses and injuries” tied to the Actavis pills, distributed by Mylan Inc.

Detroit-based Caraco fell $1.03 cents, or 23 percent, to $3.52 at 4 p.m. in New York Stock Exchange composite trading. The drop was the biggest single-day decline since Dec. 1. The company is majority owned by Sun Pharmaceutical Industries Ltd., of Mumbai.

Digoxin is sold by several makers of generic drugs to treat heart failure and abnormal heart rhythms. It is a form of digitalis, a chemical derived from foxglove plants that has been used in cardiology since the 18th century.

If you are currently taking Digitek (digoxin) and have concerns about its safety, you should consult with your doctor regarding your treatment options. Under no circumstances should you discontinue taking any medication, including Digitek (digoxin) , without first consulting with your doctor. If you or a loved one have suffered due to DIgitek (digoxin) side effects contact the Digitek Attorneys of Ennis & Ennis, P.A. by filling out our free Digitek case evaluation form or by calling the toll-free number listed below.
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