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Showing 421–440 of 1310 results

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Duloxetine Capsules 30mg (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.

Progesterone Injection 500mg (Eugia) – glass piece contamination (2024)

Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.

Class IIModerate

FDADec 27, 2024Nationwide• Eugia US LLC

Levothyroxine Tablets 75mcg (Lupin) – impurity specification (2024)

Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.

Class IIModerate

FDADec 20, 2024IN, OH• Lupin Pharmaceuticals Inc.

Medroxyprogesterone Injection (Eugia) – CGMP deviation (2024)

CGMP Deviations

Class IIModerate

FDADec 18, 2024Nationwide• Eugia US LLC

GlipiZIDE Extended-Release Tablets (Amerisource) – Dissolution Failure (2024)

Failed Dissolution Specifications:

Class IIModerate

FDADec 17, 2024Nationwide• Amerisource Health Services LLC

Ciprofloxacin Ophthalmic Solution (FDC Limited) – Defective Container (2024)

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

FDADec 16, 2024Nationwide• FDC Limited

Clobazam Tablets (Amerisource) – Foreign Tablet Contamination (2024)

Presence of Foreign Tablets/Capsules

Class IIModerate

FDADec 13, 2024Nationwide• Amerisource Health Services LLC

Dabigatran Etexilate 150mg (Ascend) – Impurity Limit Exceeded (2024)

CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

Class IIModerate

FDADec 12, 2024Nationwide• Ascend Laboratories, LLC

Dabigatran Etexilate 75mg (Ascend) – Impurity Limit Exceeded (2024)

CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

Class IIModerate

FDADec 12, 2024Nationwide• Ascend Laboratories, LLC

Chlorpromazine Tablets 25mg (Glenmark) – Impurity Limit Exceeded (2024)

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

Class IIModerate

FDADec 11, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Chlorpromazine Tablets 10mg (Glenmark) – Impurity Limit Exceeded (2024)

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

Class IIModerate

FDADec 11, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Dapsone Gel 7.5% (Viona) – Crystallization (2024)

Crystallization

Class IIModerate

FDADec 10, 2024Nationwide• VIONA PHARMACEUTICALS INC

Dapsone Gel 7.5% (VIONA) – Crystallization Issue (2024)

Crystallization

Class IIModerate

FDADec 10, 2024Nationwide• VIONA PHARMACEUTICALS INC

Duloxetine Capsules 60mg (Amerisource) – CGMP Impurity Limit (2024)

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

Class IIModerate

FDADec 6, 2024Nationwide• Amerisource Health Services LLC

Duloxetine Capsules 30mg (Breckenridge) – CGMP Impurity Limit (2024)

CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Class IIModerate

FDADec 6, 2024Nationwide• Breckenridge Pharmaceutical, Inc

Duloxetine Capsules 60mg (Breckenridge) – CGMP Impurity Limit (2024)

CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Class IIModerate

FDADec 6, 2024Nationwide• Breckenridge Pharmaceutical, Inc

Nebivolol Tablets 2.5mg (Aurobindo) – Nitrosamine Impurity (2024)

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.

Class IIModerate

FDADec 6, 2024Nationwide• Aurobindo Pharma USA Inc

Duloxetine Capsules 30mg (Amerisource) – CGMP Impurity Limit (2024)

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

Class IIModerate

FDADec 6, 2024Nationwide• Amerisource Health Services LLC

Duloxetine Capsules 60mg (Amerisource) – CGMP Impurity Limit (2024)

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

Class IIModerate

FDADec 6, 2024Nationwide• Amerisource Health Services LLC

Duloxetine Capsules 30mg (Amerisource) – CGMP Impurity Limit (2024)

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

Class IIModerate

FDADec 6, 2024Nationwide• Amerisource Health Services LLC

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