FDA Drug recall D-0834-2020
Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India,…
- FDA Drug
- Class II
- terminated
- Published 2020-02-19
On 2020-02-19 the FDA classified a Class II recall of Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India,… by Zydus Pharmaceuticals Usa, citing cGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0834-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-31 |
| Published | 2020-02-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
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
cGMP Deviations
Identifiers
| code_info | Lot #s: M804062, Exp. 01/2020; M804063, M804064, Exp. 02/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0834-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.