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

Recall Number: D-067-2013

Firm: Boehringer Ingelheim Roxane Inc

Classification: Class II

Status: Terminated

Report Date: 20121205

Initiation Date: 20121105

Termination Date: 20130918

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

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