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

FDA recall notice · announced December 5, 2012 · Boehringer Ingelheim Roxane

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

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

Reason for recall

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

Notes

Distribution: Nationwide
Lot/code information: Lot 201900 Expiration Date: JAN 2015
Quantity: 8,381 bottles
Status: Terminated
Products in this recall event:
- Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54 (D-067-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.