Drug product
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
Product summary
- Event
- Event 63630
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,381 bottles
- Official record key
drug-enforcement:D-067-2013
Official wording
Reason: Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product
Code information: Lot 201900 Expiration Date: JAN 2015
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product