Drug recall
VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm…
FDA recall event 65582 · Class II · West-Ward Pharmaceutical Corp.
Key facts
| Event ID | 65582 |
|---|---|
| Recall numbers | D-839-2013 |
| Recalling firm | West-Ward Pharmaceutical Corp. |
| Product type | Drugs |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Jun 4, 2013 |
| Report date | Aug 14, 2013 |
| Termination date | Jun 5, 2014 |
| City | Eatontown |
| State | NJ |
| Country | United States |
| FEI number | 2250102 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: