Product: Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213 India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
Reason for recall: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated: 20220126
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated