
Fesoterodine Fumarate
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Page 24 of 24 · 1,199 total recalls

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.


Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil...

CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency...

CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency...

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.

Product contains undeclared cyclamates.

Product contains undeclared cyclamates.

The firm initiated a voluntary recall after NSF testing showed that labeled ingredient quantities did not align with...

CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.

Bulk packaged dietary ingredient manufacturer product label does not declare Milk as an allergen ingredient.

Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the...

Under-processed product may contain pathogenic bacteria that could harm to humans.

Under-processed product may contain pathogenic bacteria that could harm to humans.

Under-processed product may contain pathogenic bacteria that could harm to humans.

Under-processed product may contain pathogenic bacteria that could harm to humans.

Under-processed product may contain pathogenic bacteria that could harm to humans.

Under-processed product may contain pathogenic bacteria that could harm to humans.

Under-processed product may contain pathogenic bacteria that could harm to humans.

Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may...

Foreign material. During production, the firm found pieces of blue plastic in a filter.

Foreign material. During production, the firm found pieces of blue plastic in a filter.

Foreign material. During production, the firm found pieces of blue plastic in a filter.
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