Ethacrynate Sodium for Injection — Class II drug recall D-0834-2020
Terminated recall by Zydus Pharmaceuticals USA Inc, reported 2020-02-19, distributed nationwide. cGMP Deviations
| Recall number | D-0834-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals USA Inc, Pennington, NJ, United States |
| Recall initiated | 2020-01-31 |
| Classified | 2020-02-10 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2021-10-26 |
| Distributed | Nationwide (US) |
| Quantity | 2,207 vials |
| Reason classes | cgmp |
| NDC | 68382-0246-01 |
| Lot numbers | M804062, M804063, M804064 |
| Expiration dates | 2020-01, 2020-02 |
Product
Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-246-01.
Reason for recall
cGMP Deviations
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-0834-2020. 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.