FDA Drug recall D-343-2014
Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) 10…
- FDA Drug
- Class III
- terminated
- Published 2013-12-18
On 2013-12-18 the FDA classified a Class III recall of Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) 10… by Boehringer Ingelheim Roxane, citing subPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-343-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-03-18 |
| Published | 2013-12-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Boehringer Ingelheim Roxane |
| Distribution | US |
Product
Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) 100-count bottle (NDC 0054-0097-25), Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216
Reason
SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
Identifiers
| code_info | Lot #: a) 259666A, Exp. MAR 2014; b) 259666B, Exp. MAR 2014 |
|---|
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 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-343-2014%22
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