Caraco Pharmaceutical has issued a nationwide voluntary recall to the consumer level of all Caraco brand digoxin 0.125mg and 0.25mg tablets distributed prior to March 31, 2009, which are not expired and are within the expiration date of September 2011. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. Affected NDC numbers of digoxin 0.125mg tablets are: 57664-437-88 (100-count) and 57446-437-18 (1000-count); affected NDC numbers of digoxin 0.25mg tablets are: 57664-441-88 (100-count) and 57664-441-18 (1000-count). Consumers with the recalled product should return these tablets to their pharmacy or place of purchase.
Digoxin is indicated for the treatment of mild-to-moderate heart failure (with a diuretic and an ACE inhibitor when possible) and for control of ventricular response rate in chronic atrial fibrillation.
For more information call (800) 818-4555 or visit www.fda.gov/Safety/Recalls/ArchiveRecalls/2009/ucm128443.htm.