Bumetanide Tablet
FDA Recall NDC 0832-0540
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Bumetanide (NDC 0832-0540). A significant event, classified as Class II, was initiated on Sep 19, 2018 by Upsher-smith Laboratories, Llc. The reported reason for this action was: "Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
September 2018 Class II Recall: Failed impurities/ degradation specifications
Recall Number
Class II Terminated
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Sep 19, 2018
Oct 31, 2018
44,764 bottles
Recall Profile & Regulatory Data
Event ID
81174
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Upsher Smith Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA, Puerto Rico and Guam
Termination Date
Sep 30, 2020
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
Batch or Lot Expiration Information
Lot# : 375716, Exp 4/30/2020; 372957, 372958, 372959, Exp 3/31/2020; 374541, 375717, 376688, Exp 5/31/2020
Affected Packages Involved in this Recall
0832-0540-11Product
0832-0541-11Product
0832-0541-10Product
0832-0542-11Product
0832-0542-10Product
September 2018 Class II Recall: Failed impurities/ degradation specifications
Recall Number
Class II Terminated
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Sep 19, 2018
Oct 31, 2018
29,080 bottles
Recall Profile & Regulatory Data
Event ID
81174
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Upsher Smith Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA, Puerto Rico and Guam
Termination Date
Sep 30, 2020
Product Description
Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11
Batch or Lot Expiration Information
Lot# : 372461, 372952, 372954, 372955, 373624, 374539, Exp 3/31/2020; 375719, 375721, 376684, Exp 5/31/2020
Affected Packages Involved in this Recall
0832-0540-11Product
0832-0541-11Product
0832-0541-10Product
0832-0542-11Product
0832-0542-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
