# FDA recall D-1045-2017

> **West-Ward Pharmaceuticals Corp.** · Class II · drug recall initiated 2016-10-03.

## Product

Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01

## Reason for recall

Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1045-2017
- **Recalling firm:** West-Ward Pharmaceuticals Corp.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-10-03
- **Report date:** 2016-11-30
- **Termination date:** 2017-12-26

- **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-1045-2017

## Citation

> AI Analytics. FDA recall D-1045-2017. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1045-2017. Source: US FDA. Licensed CC0.

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