6 FDA recalls mention Bumetanide. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Bumetanide.
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Reason Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Reason Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Reason Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point…
Reason Labeling: Label Mixup: BUMETANIDE, Tablet, 1 mg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC…
Reason Labeling: Label Mixup: BUMETANIDE, Tablet, 0.5 mg, Rx only may have potentially been mislabeled as the following drug: ERYTHROMYCIN DR EC, Tablet…
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