Recalls / Class II
Class IID-067-2013
Product
Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54
- Affected lot / code info
- Lot 201900 Expiration Date: JAN 2015
Why it was recalled
Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product
Recalling firm
- Firm
- Boehringer Ingelheim Roxane Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1809 Wilson Rd, N/A, Columbus, Ohio 43228-9579
Distribution
- Quantity
- 8,381 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-11-05
- FDA classified
- 2012-11-26
- Posted by FDA
- 2012-12-05
- Terminated
- 2013-09-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-067-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.