Drug recall
VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured…
FDA recall event 69539 · Class II · West-Ward Pharmaceutical Corp.
Key facts
| Event ID | 69539 |
|---|---|
| Recall numbers | D-0172-2015 |
| Recalling firm | West-Ward Pharmaceutical Corp. |
| Product type | Drugs |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point. |
| Initiation date | Oct 2, 2014 |
| Report date | Nov 5, 2014 |
| Termination date | Aug 3, 2015 |
| 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: