Class II · Moderate risk
Bumetanide Tablets
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.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11
Affected NDC
0832-0541-11
Compare with the code on your package — it is the most precise check available.
Drug: Bumetanide
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Bumetanide NDC 00832-0541 |
1 mg/1 | Tablet Oral |
Upsher-Smith Laboratories, LLC | Rx |
- Recalling firm
- Upsher Smith Laboratories, Inc.
- NDC code
- 0832-0541-11
- Origin
- MN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0280-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Bumetanide recalls
See all
Class II · Moderate risk
Bumetanide Tablets
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Class III · Low risk
Bumetanide Tablets USP 0.5 mg. Rx Only
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
Bumetanide
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
Bumetanide
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.
Other recalls by Upsher Smith Laboratories, Inc.
All 2018 recalls
Class II · Moderate risk
Bexarotene Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Bumetanide Tablets
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Class III · Low risk
Oxandrolone Tablets
Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however, packaged in the correct finished product shipper, labeled with the correct shipper bar code label, sealed with tamper-evident tape and erroneously shipped to Upsher-Smith.
Class III · Low risk
Divalproex Sodium Delayed-Release Tablets
Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.
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