FDA Recall – Digoxin recalled by Caraco Pharmaceutical Laboratories

June 12, 2009

Another Digoxin recall was announced by the Food & Drug Administration (FDA) on March 31, 2009.  The digoxin lawyers at our firm, Fears Nachawati, continue to investigate and actively pursue claims and cases where consumers have been injured by Digoxin and Digitek.

The FDA posted information listed below about the recall.

Caraco Pharmaceutical Laboratories, Ltd. (NYSE AMEX: CPD), a generic pharmaceutical company, 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 Food and Drug Administration. 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. The recalled lots of Digoxin are listed below.

Caraco Digoxin 0.125 mg is a scored round biconvex yellow tablet imprinted with “437”

Caraco Digoxin 0.25 mg is a scored round biconvex white tablet imprinted with “441”

NDC Numbers:

Digoxin Tablets, USP, 0.125 mg
57664-437-88 (100-count)
57664-437-18 (1000-count)

Digoxin Tablets, USP, 0.25 mg
57664-441-88 (100-count)
57664-441-18 (1000-count)

Our firm is actively pursuing digitek and digoxin pharmaceutical companies on a nationwide basis.  If you or a loved one has been harmed by digoxin or digitek, call our firm for legal help or for a free legal consultation about your potential digoxin or digitek claim.  Toll Free 1.866.705-7584 or by email at infon@fnlawfirm.com

 

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