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Showing 441–460 of 1310 results

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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

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

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.

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 175mcg Tablets (Mylan) – Potency Variation (2024)

Subpotent and Superpotent Drug

Class IIModerate

FDANov 19, 2024Nationwide• Mylan Institutional, Inc.

Duloxetine DR Capsules 30mg (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 137mcg Tablets (Mylan) – Potency Variation (2024)

Subpotent and Superpotent Drug

Class IIModerate

FDANov 19, 2024Nationwide• Mylan Institutional, Inc.

Levothyroxine Sodium 112mcg Tablets (Mylan) – Potency Variation (2024)

Subpotent and Superpotent Drug

Class IIModerate

FDANov 19, 2024Nationwide• Mylan Institutional, Inc.

Levothyroxine Sodium 125mcg 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.

Duloxetine DR Capsules 20mg (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 112mcg Tablets (Viatris) – Potency Variation (2024)

Superpotent Drug and Subpotent Drug: potency failures obtained

Class IIModerate

FDANov 18, 2024Nationwide• Viatris Inc

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