# FDA recall D-343-2014

> **Boehringer Ingelheim Roxane Inc** · Class III · drug recall initiated 2013-03-18.

## 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 for recall

SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-343-2014
- **Recalling firm:** Boehringer Ingelheim Roxane Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-03-18
- **Report date:** 2013-12-18
- **Termination date:** 2014-02-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Columbus, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-343-2014

## Citation

> AI Analytics. FDA recall D-343-2014. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-343-2014. Source: US FDA. Licensed CC0.

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