Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand)

Audience: Pharmacists, cardiology healthcare professionals, consumers

05/12/2009 - AS Medication Solutions, LLC, a drug repackage company, announced today that all tablets of Caraco brand Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of August, 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. Caraco Pharmaceutical Laboratories, Ltd manufactured the recalled tablets. The recalled product is a scored round biconvex white tablet imprinted with “441”, with an NDC number of 54569-5758-0 (30-count). Consumers with the product that are within expiration should return these products to their pharmacy or place of purchase.

Read the complete MedWatch 2009 Safety summary, including a link to the original April 1 alert and the current firm press release, at:

http://www.fda.gov/medwatch/safety/2009/safety09.htm#Digoxin