7 FDA recalls mention Bisoprolol. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Bisoprolol.
Reason cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Reason Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Reason Failed Impurities/Degradation Specifications
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Reason Failed Dissolution Specifications: OOS result during stability testing
Reason Labeling: Label Mixup; BISOPROLOL FUMARATE Tablet, 5 mg may be potentially mislabeled as: ESTROPIPATE, Tablet, 0.75 mg, NDC 00591041401, Pedigree…
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