VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets — Class II drug recall D-0172-2015
Terminated recall by West-Ward Pharmaceutical Corp., reported 2014-11-05, distributed in GA. Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
| Recall number | D-0172-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | West-Ward Pharmaceutical Corp., Eatontown, NJ, United States |
| Recall initiated | 2014-10-02 |
| Classified | 2014-10-30 |
| Reported by FDA | 2014-11-05 |
| Terminated | 2015-08-03 |
| Distributed | GA |
| Quantity | 5,596 hdpe |
| Reason classes | specification failure |
| NDC | 61748-0011-01 |
| Lot numbers | 07/15, 68975A, 68976 |
Product
VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured for VersaPharm Incorporated Marietta, GA 30065-1509 Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 61748-011-01
Reason for recall
Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0172-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.