Drug recall
Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals…
FDA recall event 85709 · Class III · West-Ward Columbus Inc
Key facts
| Event ID | 85709 |
|---|---|
| Recall numbers | D-1282-2020 |
| Recalling firm | West-Ward Columbus Inc |
| Product type | Drugs |
| Products | Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC: 0054-0415-25. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants. |
| Initiation date | May 13, 2020 |
| Report date | May 27, 2020 |
| Termination date | Oct 2, 2022 |
| City | Columbus |
| State | OH |
| Country | United States |
| FEI number | 1510690 |
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: