# FDA recall D-691-2013

> **West-ward Pharmaceutical Corp.** · Class III · drug recall initiated 2013-05-13.

## Product

Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir, NC, Dist. by: West-ward Pharmaceutical Corp., Eatontown, NJ --- NDC 0143-9689-10

## Reason for recall

Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)

## Distribution

Nationwide

## Key facts

- **Recall number:** D-691-2013
- **Recalling firm:** West-ward Pharmaceutical Corp.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-05-13
- **Report date:** 2013-07-17
- **Termination date:** 2015-03-17

- **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-691-2013

## Citation

> AI Analytics. FDA recall D-691-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-691-2013. Source: US FDA. Licensed CC0.

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