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Showing 481–500 of 505 results

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Atomoxetine Capsules 40mg (Glenmark) – Impurity Risk (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine Capsules 60mg (Glenmark) – Impurity Risk (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine 25mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine 18mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine 25mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine 80mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine 60mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine Capsules 100mg (Glenmark) – Impurity Risk (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine 80mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine 10mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine 10mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine 100mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine Capsules 40mg (Glenmark) – Impurity Risk (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine 18mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

HydrALAZINE 50mg Tablets (SKY) – Specification Failure (2025)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAJan 24, 2025Nationwide• SKY PACKAGING

HydrALAZINE 25mg Tablets (SKY) – Specification Failure (2025)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAJan 24, 2025Nationwide• SKY PACKAGING

Timolol Maleate Eye Solution (FDC) – Defective Container (2025)

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

Class IIModerate

FDAJan 23, 2025IN, NJ• FDC Limited

Carvedilol Tablets 25mg (Glenmark) – Impurity Risk (2025)

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

Class IIModerate

FDAJan 22, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Carvedilol Tablets 12.5mg (Glenmark) – Impurity Risk (2025)

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

Class IIModerate

FDAJan 22, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Phenylephrine Injection (Provepharm) – Particulate Matter (2025)

Presence of Particulate Matter.

FDAJan 21, 2025Nationwide• Provepharm Inc.

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