CPD: Voluntary Recall of Digoxin Tablets

Posted on: Tue, 31 Mar 2009 15:01:00 EDT


Symbols: CPD
Ridgeland, MS, MAR 31, 2009 (EventX/Knobias.com via COMTEX) --
CPD | Quote | Chart | News | PowerRating -- By Fain Hughes, fhughes@knobias.com

Caraco Pharmaceutical Laboratories, Ltd. (CPD) announced that all tablets of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011, are being voluntarily recalled to the consumer level. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. The recalled tablets were manufactured by Caraco Pharmaceutical Laboratories, Ltd. This recall is being conducted with the knowledge of the FDA.

Digoxin is a drug product used to treat heart failure and abnormal heart rhythms. It has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. Consequently, as a precautionary measure, Caraco is recalling these tablets to the consumer level to minimize any potential risk to patients.

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For full details on Caraco Pharm Labs (CPD) CPD. Caraco Pharm Labs (CPD) has Short Term PowerRatings at TradingMarkets. Details on Caraco Pharm Labs (CPD) Short Term PowerRatings is available at This Link.

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