Ethacrynic Acid Tablets USP — Class III drug recall D-1282-2020
Terminated recall by West-Ward Columbus Inc, reported 2020-05-27, distributed nationwide. Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
| Recall number | D-1282-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | West-Ward Columbus Inc, Columbus, OH, United States |
| Recall initiated | 2020-05-13 |
| Classified | 2020-05-29 |
| Reported by FDA | 2020-05-27 |
| Terminated | 2022-10-02 |
| Distributed | Nationwide (US) |
| Quantity | 3,336 bottles |
| Reason classes | specification failure |
| NDC | 00054-0415-25 |
| Lot numbers | AA4424A |
| Expiration dates | 2020-07-31 |
Product
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.
Reason for recall
Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
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-1282-2020. 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.