VersaPharm Incorporated — Class II drug recall D-839-2013
Terminated recall by West-Ward Pharmaceutical Corp., reported 2013-08-14, distributed in GA. Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for descri
| Recall number | D-839-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | West-Ward Pharmaceutical Corp., Eatontown, NJ, United States |
| Recall initiated | 2013-06-04 |
| Classified | 2013-08-02 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2014-06-05 |
| Distributed | GA |
| Quantity | 118 bottles |
| Reason classes | specification failure |
| NDC | 61748-0014-06 |
| Lot numbers | 03/14, 69968B |
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.
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-839-2013. 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.