# FDA recall D-1438-2012

> **West-ward Pharmaceutical Corp.** · Class II · drug recall initiated 2012-04-13.

## Product

Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single Dose Vial, packaged in 10-count x 10 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ  07724 USA under the labels a) NOVAPLUS (NDC 0143-9703-10), b) West-Ward (NDC 0143-9782-10).

## Reason for recall

Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.

## Distribution

All lots were distributed throughout the US.

## Key facts

- **Recall number:** D-1438-2012
- **Recalling firm:** West-ward Pharmaceutical Corp.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-04-13
- **Report date:** 2012-08-08
- **Termination date:** 2015-01-16

- **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-1438-2012

## Citation

> AI Analytics. FDA recall D-1438-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1438-2012. Source: US FDA. Licensed CC0.

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