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Showing 541–560 of 1639 results

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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 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

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 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

Timolol Maleate Solution (FDC) – 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 5, 2024IN, NJ• FDC Limited

Nitrofurantoin Capsules 100mg (AvKARE) – Dissolution Failure (2024)

Failed Dissolution Specifications

Class IIModerate

FDADec 4, 2024Nationwide• AvKARE

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

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

Class IIModerate

FDADec 2, 2024Nationwide• RemedyRepack Inc.

Cinacalcet Tablets 30mg (AvKARE) – Nitrosamine Impurity (2024)

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

Class IIModerate

FDANov 27, 2024Nationwide• AvKARE

Cinacalcet Tablets 90mg (AvKARE) – Nitrosamine Impurity (2024)

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

Class IIModerate

FDANov 27, 2024Nationwide• AvKARE

Cinacalcet Tablets 60mg (AvKARE) – Nitrosamine Impurity (2024)

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

Class IIModerate

FDANov 27, 2024Nationwide• AvKARE

Olanzapine Tablets 2.5mg (Macleods) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications

Class IIModerate

FDANov 25, 2024Nationwide• Macleods Pharmaceuticals Ltd

VCF Contraceptive Gel (Apothecus) – Assay Deviation (2024)

CGMP deviations: out of specifications for assay

Class IIModerate

FDANov 22, 2024Nationwide• Apothecus Pharmaceutical Corp.

Dihydroergotamine Mesylate Injection (Provepharm Inc.) – Discoloration (2024)

Discoloration

Class IIModerate

FDANov 22, 2024Nationwide• Provepharm Inc.

Javygtor Tablets 100mg (Dr. Reddy's) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications

FDANov 22, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Technetium Tc 99m Sulfur Colloid Kit (Jubilant Radiopharma) – Stability Failure (2024)

Failed Stability Specifications

Class IIModerate

FDANov 22, 2024Nationwide• Jubilant Draximage Inc., dba Jubilant Radiopharma

Levothyroxine Sodium 125mcg Tablets (Mylan) – Potency Variation (2024)

Subpotent and Superpotent Drug

Class IIModerate

FDANov 19, 2024Nationwide• Mylan Institutional, Inc.

Duloxetine DR Capsules 60mg (Rising Pharma) – N-nitroso Impurity (2024)

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

Class IIModerate

FDANov 19, 2024Nationwide• Rising Pharma Holding, Inc.

Levothyroxine Sodium 100mcg Tablets (Mylan) – Potency Variation (2024)

Subpotent and Superpotent Drug

Class IIModerate

FDANov 19, 2024Nationwide• Mylan Institutional, Inc.

Levothyroxine Sodium 150mcg Tablets (Mylan) – Potency Variation (2024)

Subpotent and Superpotent Drug

Class IIModerate

FDANov 19, 2024Nationwide• Mylan Institutional, Inc.

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