# FDA recall D-0420-2015

> **West-Ward Pharmaceutical Corporation** · Class III · drug recall initiated 2015-02-16.

## Product

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

## Reason for recall

Failed Impurities/Degradation Specifications; 12 month stability testing.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0420-2015
- **Recalling firm:** West-Ward Pharmaceutical Corporation
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-02-16
- **Report date:** 2015-04-01
- **Termination date:** 2016-07-26

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0420-2015

## Citation

> AI Analytics. FDA recall D-0420-2015. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/D-0420-2015. Source: US FDA. Licensed CC0.

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