FDA Recall Terminated Historical recordClass II
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
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
