Caraco Pharmaceutical Laboratories has issued a recall of its Digoxin USP tablets (.125mg & .25 mg) after certain lots were manufactured with either more or less of the active ingredient that should be contained. Patients taking the drug should check their prescriptions immediately to see if their medication is part of the recall.
Recall details
According to Caraco Pharmaceutical Laboratories, a generic drug manufacturer, and the U.S. Food & Drug Administration (FDA), Caraco brand Digoxin USP, 0.125 mg (which is a scored round biconvex yellow tablet imprinted with “437”), and Digoxin USP, 0.25 mg (which is a scored round biconvex white tablet imprinted with “441”), are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. The tablets were distributed prior to March 31, 2009 and have an expiration date of September 2011.
According to the FDA:
Digoxin [which is a generic version of GlaxoSmithKline Plc's drug Lanoxin] is a drug product used to treat heart failure and abnormal heart rhythms and 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 [a very slow heartbeat]. 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.
Consumers should return defective Caraco products
Consumers with the recalled product are being advised to return products to their pharmacy or place of purchase and to contact the FDA’s MedWatch Safety Program if they experience any adverse reactions. For additional information, see Caraco’s press release at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Digoxin/.
More product liability litigation likely
This is not the first time that digoxin has been recalled. A similar recall was issued in April 2008 due to oversized Digitek, a different brand of the generic heart drug digoxin manufactured by Actavis Totowa, which was released into the marketplace – and had devastating results.
Digoxin toxicity reportedly led to 667 deaths from double strength Digitek tablets in 2007, according to a study published by the Center for Public Integrity and the FDA late last year. Actavis and other digoxin distributors are currently facing many lawsuits. Federal cases are consolidated in Multi District Litigation in the U.S. District Court for the Southern District of West Virginia and drug litigation attorneys predict that more litigation is likely in the near future.
