Class II
Terminated
Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11
- Company
- Upsher Smith Laboratories, Inc.
- Recall Initiated
- September 19, 2018
- Posted
- October 31, 2018
- Recall Number
- D-0280-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 44,764 bottles
- Firm Location
- Maple Grove, MN, United States
Reason for Recall
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Distribution
Nationwide USA, Puerto Rico and Guam
Lot / Code Info
Lot#: 375716, Exp 4/30/2020; 372957, 372958, 372959, Exp 3/31/2020; 374541, 375717, 376688, Exp 5/31/2020
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