Caraco Pharmaceutical Laboratories, Ltd, 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 Pharma Labs. 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 labelled 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 labelled 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.

Consumers with the products with the following NDC codes that are within expiration should return these products to their pharmacy or place of purchase.

As per product identification provided by the company Caraco Digoxin 0.125 mg is a scored round biconvex yellow tablet imprinted with '437' and Caraco Digoxin 0.25 mg is a scored round biconvex white tablet imprinted with '441'.

Patients using Caraco's Digoxin tablets, USP, 0.125 mg or 0.25 mg, who have medical questions should contact their healthcare provider for additional instructions or guidance.

Retailers who have this product should return the product to their place of purchase. Retailers can call Caraco customer service at (800) 818-4555, Monday through Friday, 8:00 a.m. - 5:00 p.m. EDT, for instructions on how to return the affected product or for any other inquiries related to this action.

Detroit-based Caraco Pharmaceutical Laboratories, Ltd, develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers.