Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54
Reported: December 5, 2012 Initiated: November 5, 2012 #D-067-2013
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
Details
- Recalling Firm
- Boehringer Ingelheim Roxane Inc
- Units Affected
- 8,381 bottles
- Distribution
- Nationwide
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54. Recalled by Boehringer Ingelheim Roxane Inc. Units affected: 8,381 bottles.
Why was this product recalled? ▼
Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 5, 2012. Severity: Moderate. Recall number: D-067-2013.
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