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
Recall initiated: 20200131
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated