Class II · Moderate risk Terminated
Bumetanide Tablets
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Bumetanide Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
What was recalled
Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11
- Recalling firm
- Upsher Smith Laboratories, Inc.
- NDC code
- 0832-0542-11
- Origin
- MN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0281-2019
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Bumetanide recalls
See all
Class II · Moderate risk Terminated
Bumetanide Tablets
Reason Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Class III · Low risk Terminated
Bumetanide Tablets USP 0.5 mg. Rx Only
Reason Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.
Class II · Moderate risk Terminated
Bumetanide
Reason Labeling: Label Mixup: BUMETANIDE, Tablet, 1 mg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000815, Pedigree: W003218, EXP: 6/17/2014.
Class II · Moderate risk Terminated
Bumetanide
Reason Labeling: Label Mixup: BUMETANIDE, Tablet, 0.5 mg, Rx only may have potentially been mislabeled as the following drug: ERYTHROMYCIN DR EC, Tablet, 250 mg, NDC 24338012213, Pedigree: AD46426_13, EXP: 5/15/2014.
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