D-067-2013 Class II Terminated
FDA drug recall D-067-2013 was initiated by Boehringer Ingelheim Roxane Inc on November 5, 2012 and is designated Class II. Reason for recall: Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product The recall status is terminated (terminated September 18, 2013). Affected quantity: 8,381 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 5, 2012
- Initiation Date
- November 5, 2012
- Termination Date
- September 18, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,381 bottles
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
Distribution Pattern
Nationwide
Code Information
Lot 201900 Expiration Date: JAN 2015