FDA Drug recall D-002-2014
Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc
- FDA Drug
- Class II
- terminated
- Published 2013-11-27
On 2013-11-27 the FDA classified a Class II recall of Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc by Boehringer Ingelheim Roxane, citing resuspension Problems: Recalled lot did not meet resuspendability requirements.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-002-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-03 |
| Published | 2013-11-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Boehringer Ingelheim Roxane |
| Distribution | US |
Product
Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59
Reason
Resuspension Problems: Recalled lot did not meet resuspendability requirements.
Identifiers
| code_info | Lot # 161304B, Exp. OCT 2013 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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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
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All Boehringer Ingelheim Roxane recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-002-2014%22
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