Pradaxa — Class II drug recall D-067-2013
Terminated recall by Boehringer Ingelheim Roxane Inc, reported 2012-12-05, distributed nationwide. Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quali
| Recall number | D-067-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boehringer Ingelheim Roxane Inc, Columbus, OH, United States |
| Recall initiated | 2012-11-05 |
| Classified | 2012-11-26 |
| Reported by FDA | 2012-12-05 |
| Terminated | 2013-09-18 |
| Distributed | Nationwide (US) |
| Quantity | 8,381 bottles |
| Reason classes | packaging |
| NDC | 00597-0149-54 |
| Lot numbers | 201900 |
| Expiration dates | 2015-01-20 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-067-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.