# FDA recall D-1139-2015

> **West-Ward Pharmaceutical Corp.** · Class III · drug recall initiated 2015-05-13.

## Product

Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dose Vials per Carton, Manufactured by: West-Ward, Eatontown, NJ 07724 USA, NDC 0641-6028-25.

## Reason for recall

Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1139-2015
- **Recalling firm:** West-Ward Pharmaceutical Corp.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-05-13
- **Report date:** 2015-06-24
- **Termination date:** 2016-04-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Eatontown, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1139-2015

## Citation

> AI Analytics. FDA recall D-1139-2015. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-1139-2015. Source: US FDA. Licensed CC0.

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