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.
Other recalls by Boehringer Ingelheim Roxane
- FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, O…
FDA Drug · Class III · 2015-10-21 · Boehringer Ingelheim Roxane - FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, O…
FDA Drug · Class III · 2015-10-21 · Boehringer Ingelheim Roxane - COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuation*, 4 Grams, 120 Metered Doses per inha…
FDA Drug · Class II · 2015-08-05 · Boehringer Ingelheim Roxane - Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc
FDA Drug · Class II · 2015-06-03 · Boehringer Ingelheim Roxane - OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only
FDA Drug · Class III · 2014-08-06 · Boehringer Ingelheim Roxane
All Boehringer Ingelheim Roxane recalls
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.