FDA Drug recall D-067-2013
Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridge…
- FDA Drug
- Class II
- terminated
- Published 2012-12-05
On 2012-12-05 the FDA classified a Class II recall of Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridge… by Boehringer Ingelheim Roxane, citing defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-067-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-05 |
| Published | 2012-12-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Boehringer Ingelheim Roxane |
| Distribution | US |
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
Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product
Identifiers
| code_info | Lot 201900 Expiration Date: JAN 2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-067-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.