# FDA recall D-1486-2014

> **Boehringer Ingelheim Roxane Inc** · Class III · drug recall initiated 2014-07-28.

## Product

OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only.  Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41.

## Reason for recall

Failed Stability Specifications: Out of specification result for preservative sodium benzoate.

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-1486-2014
- **Recalling firm:** Boehringer Ingelheim Roxane Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-07-28
- **Report date:** 2014-08-06
- **Termination date:** 2015-05-29

- **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-1486-2014

## Citation

> AI Analytics. FDA recall D-1486-2014. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1486-2014. Source: US FDA. Licensed CC0.

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