Why it was recalled
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Product description
Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11
Lot numbers, UPCs & expiration codes
Lot#: 375716, Exp 4/30/2020; 372957, 372958, 372959, Exp 3/31/2020; 374541, 375717, 376688, Exp 5/31/2020
Where it was sold
Nationwide USA, Puerto Rico and Guam
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0280-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 19, 2018
- FDA report date
- Oct 31, 2018
- Quantity
- 44,764 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Upsher Smith Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0280-2019, exactly as published.
Show all FDA fields
- City
- Maple Grove
- State
- MN
- Status
- Terminated
- Country
- United States
- Event ID
- 81174
- Address
- 6701 Evenstad Dr N
- Code information
- Lot#: 375716, Exp 4/30/2020; 372957, 372958, 372959, Exp 3/31/2020; 374541, 375717, 376688, Exp 5/31/2020
- Postal code
- 55369-6026
- Report date
- Oct 31, 2018
- Product type
- Drugs
- Recall number
- D-0280-2019
- Classification
- Class II
- Recalling firm
- Upsher Smith Laboratories, Inc.
- Product quantity
- 44,764 bottles
- Termination date
- Sep 30, 2020
- Reason for recall
- Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11
- Distribution pattern
- Nationwide USA, Puerto Rico and Guam
- Recall initiation date
- Sep 19, 2018
- Initial firm notification
- Letter
- Center classification date
- Nov 21, 2018