Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehrin...
FDA Recall #D-067-2013 — Class II — November 5, 2012
Product Description
Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54
Reason for Recall
Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product
Recalling Firm
Boehringer Ingelheim Roxane Inc — Columbus, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
8,381 bottles
Distribution
Nationwide
Code Information
Lot 201900 Expiration Date: JAN 2015
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated