# FDA recall D-1414-2014

> **West-Ward Pharmaceutical Corp.** · Class II · drug recall initiated 2014-05-20.

## Product

Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ  07724; c) 30-count bottles, NDC 61748-013-30, d) 100-count bottles, NDC 61748-013-01, e) 1000-count bottles, NDC 61748-013-10, Mfd. for: VersaPharm Incorporated, Marietta, GA  30062; Mfd. by: West-ward Pharmaceutical Corp., Eatontown, NJ  07724.

## Reason for recall

Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1414-2014
- **Recalling firm:** West-Ward Pharmaceutical Corp.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-05-20
- **Report date:** 2014-07-09
- **Termination date:** 2015-05-22

- **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-1414-2014

## Citation

> AI Analytics. FDA recall D-1414-2014. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-1414-2014. Source: US FDA. Licensed CC0.

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