Class II · Moderate risk Ongoing
Bisoprolol Fumarate and Hydrochlorothiazide tablets
Reason cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
BISOPROLOL FUMARATE Tablet
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Mixup; BISOPROLOL FUMARATE Tablet, 5 mg may be potentially mislabeled as: ESTROPIPATE, Tablet, 0.75 mg, NDC 00591041401, Pedigree: AD34934_4, EXP: 5/10/2014.
What was recalled
BISOPROLOL FUMARATE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 29300012601
- Recalling firm
- Aidapak Services, LLC
- Origin
- WA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-542-2014
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 Bisoprolol recalls
See all
Class III · Low risk Ongoing
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Reason Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Class III · Low risk Terminated
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Bisoprolol Fumarate tablets
Reason Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
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