Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM…
Reason cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
129 FDA recalls mention Hydrochlorothiazide. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Hydrochlorothiazide.
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 Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets…
Reason Presence of foreign substance: plastic-like substance.
Reason Failed Impurities/Degradation Specifications
Reason Failed Impurity/Degradation Specifications
Reason Failed Impurity/Degradation Specifications
Reason CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Reason Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the…
Reason Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the…
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Reason CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Reason CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Reason CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Reason CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Reason CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Reason CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
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