Drug 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.
D-0834-2020
Product summary
- Event
- Event 84848
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2207 Vials
- Official record key
drug-enforcement:D-0834-2020
Official wording
Reason: cGMP Deviations
Code information: Lot #s: M804062, Exp. 01/2020; M804063, M804064, Exp. 02/2020
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Manufacturing or process control
cGMP Deviations