Recalls / Class II
Class IID-0280-2019
Product
Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11
- Brand name
- Bumetanide
- Generic name
- Bumetanide
- Active ingredient
- Bumetanide
- Route
- Oral
- NDCs
- 0832-0540, 0832-0541, 0832-0542
- FDA application
- ANDA209916
- Affected lot / code info
- Lot#: 375716, Exp 4/30/2020; 372957, 372958, 372959, Exp 3/31/2020; 374541, 375717, 376688, Exp 5/31/2020
Why it was recalled
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Recalling firm
- Firm
- Upsher Smith Laboratories, Inc.
- Manufacturer
- Upsher-Smith Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6701 Evenstad Dr N, N/A, Maple Grove, Minnesota 55369-6026
Distribution
- Quantity
- 44,764 bottles
- Distribution pattern
- Nationwide USA, Puerto Rico and Guam
Timeline
- Recall initiated
- 2018-09-19
- FDA classified
- 2018-11-21
- Posted by FDA
- 2018-10-31
- Terminated
- 2020-09-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0280-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.