# FDA recall D-839-2013

> **West-Ward Pharmaceutical Corp.** · Class II · drug recall initiated 2013-06-04.

## Product

VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorporated Marietta, GA 30065-1509; Mfd. by: West-ward Pharmaceuticals Corp., Eatontown, NJ 07724  NDC 61748-014-06,

## Reason for recall

Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description  testing  for a surface defect of ink.

## Distribution

GA

## Key facts

- **Recall number:** D-839-2013
- **Recalling firm:** West-Ward Pharmaceutical Corp.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-06-04
- **Report date:** 2013-08-14
- **Termination date:** 2014-06-05

- **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-839-2013

## Citation

> AI Analytics. FDA recall D-839-2013. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-839-2013. Source: US FDA. Licensed CC0.

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