Boehringer Ingelheim Roxane Inc recalls Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceu

Recalled December 5, 2012 · FDA recall D-067-2013 · Boehringer Ingelheim Roxane

Hazard

Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product · FDA Class II

Units

8,381 bottles

Sold at

Nationwide

Description

Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product

Product

Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54

Manufacturer(s)

Boehringer Ingelheim Roxane Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →