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Showing 401–420 of 1310 results

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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 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 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 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 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

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

Failed Impurities/Degradation Specifications

Class IIModerate

FDAJan 24, 2025Nationwide• SKY PACKAGING

HydrALAZINE 50mg 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 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

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

Lorazepam Tablets 1mg (Major) – Potency Concern (2025)

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

Class IIModerate

FDAJan 21, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Lorazepam Tablets 0.5mg (Major) – Potency Concern (2025)

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

Class IIModerate

FDAJan 21, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Lorazepam Tablets 2mg (Major) – Potency Concern (2025)

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

Class IIModerate

FDAJan 21, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Inflectra Injection (McKesson) – Distribution Error (2025)

cGMP Deviations: Product intended for quarantine was inadvertently distributed.

Class IIModerate

FDAJan 17, 2025Nationwide• McKesson

Duloxetine Capsules (Harvard Drug Group) – Nitrosamine Impurity (2025)

CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit

Class IIModerate

FDAJan 13, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Granix Injection (Teva) – Failed Stability Test (2025)

Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit

Class IIModerate

FDAJan 10, 2025Nationwide• Teva Pharmaceuticals USA, Inc

Clobazam Tablets (Amerisource) – Foreign Tablets (2025)

Presence of Foreign Tablets/Capsules

Class IIModerate

FDAJan 7, 2025Nationwide• Amerisource Health Services LLC

Duloxetine Capsules 20mg (Rising Pharma) – CGMP impurity risk (2024)

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Class IIModerate

FDADec 30, 2024Nationwide• Rising Pharma Holding, Inc.

Metformin ER Tablets 500mg (Granules) – foreign tablet found (2024)

Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.

Class IIModerate

FDADec 30, 2024IN, OH• Granules Pharmaceuticals Inc.

Duloxetine Capsules 60mg (Rising Pharma) – CGMP impurity risk (2024)

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Class IIModerate

FDADec 30, 2024Nationwide• Rising Pharma Holding, Inc.

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