Digitek

More Caraco Brand Digoxin Tablets Recalled 

May 11, 2009—All lots of 0.25 mg Digoxin tablets with an expiration date of August 2011 that were manufactured by Caraco Pharmacuetical Laboratories Ltd. and packaged and sold by AS Medication Solutions, LLC of Libertyville, Illinois prior to March 31, 2009 are being recalled. The recalled tablets may differ in size and could have more or less of the active ingredient, digoxin.
Digoxin is a prescription drug used to treat heart failure and abnormal heart rhythms. The existence of a 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, bradycardia and death. A lower-than-labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability.

Caraco Digoxin tablets subject to this recall:

Digoxin Tablets, USP, 0.25 mg    NDC# 54569-5758-0 (30 count).  This is a scored round biconvex white tablet imprinted with “441”. 

Other Digoxin Recalls:

Caraco Pharmaceutical Labs Recalls All Lots of Digoxin Tablets

March 31, 2009 - Caraco Pharmaceutical Laboratories, Ltd, a generic pharmaceutical company is voluntarily recalling all tablets of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009 because they may differ in size and therefore could have more or less of the active ingredient, digoxin. The recalled pills have an expiration date of September, 2011.

Caraco Digoxin tablets subject to this recall:

Caraco Digoxin Tablets, USP, 0.125 mg:  NDC #s:  57664-437-88 (100-count) and 57664-437-18 (1000-count).  This is a scored round biconvex yellow tablet imprinted with "437".

Caraco Digoxin USP, 0.25 mg:  NDC #s: 57664-441-88 (100-count) and 57664-441-18 (1000-count).  This is a scored round biconvex white tablet imprinted with "441".

Actavis Recalls All Lots of Bertek and UDL Laboratories Digitek (digoxin) Tablets

April 25, 2008 - Actavis Totowa LLC, (formerly Amide Pharmaceutical, Inc.) a United States manufacturing division of the generic pharmaceutical company Actavis Group, is initiating a voluntary nationwide Class I recall of Digitek (digoxin) tablets in all strengths.  The product is being recalled due to the possibility that tablets with double the appropriate thickness may have been commercially released.  These tablets may contain twice the approved level of active ingredient than is appropriate.

According to the company, the existence of double-strength Digitek tablets poses a risk of Digitalis toxicity in patients with renal failure.  Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive Digitalis intake.  Several reports of illness and injuries have been received.

The products are distributed by Mylan Pharmaceuticals, Inc. under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label. Consumers are being advised to contact their health care providers if they have any medical questions regarding the recalled Digitek tablets.  Do not discontinue any medication without first consulting your doctor.

Note - Do not change medications without first consulting your doctor.

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