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Showing 601–620 of 14362 results

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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.

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

Subpotent and Superpotent Drug

Class IIModerate

FDANov 19, 2024Nationwide• Mylan Institutional, Inc.

Levothyroxine Sodium 137mcg Tablets (Mylan) – Potency Variation (2024)

Subpotent and Superpotent Drug

Class IIModerate

FDANov 19, 2024Nationwide• Mylan Institutional, 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 200mcg Tablets (Viatris) – Potency Variation (2024)

Superpotent Drug and Subpotent Drug: potency failures obtained

Class IIModerate

FDANov 18, 2024Nationwide• Viatris Inc

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

Superpotent Drug and Subpotent Drug: potency failures obtained

Class IIModerate

FDANov 18, 2024Nationwide• Viatris Inc

Clonazepam Orally Disintegrating Tablet 2 mg (Endo) – Incorrect Label (2024)

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.

FDANov 18, 2024Nationwide• Endo USA, Inc.

Clonazepam Orally Disintegrating 1mg (Endo) – Labeling Error (2024)

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.

FDANov 18, 2024Nationwide• Endo USA, Inc.

Levothyroxine Sodium Tablets 88 mcg (Viatris) – Potency Failures (2024)

Superpotent Drug and Subpotent Drug: potency failures obtained

Class IIModerate

FDANov 18, 2024Nationwide• Viatris Inc

Clonazepam Orally Disintegrating Tablet 0.25 mg (Endo) – Incorrect Label (2024)

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.

FDANov 18, 2024Nationwide• Endo USA, Inc.

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

Superpotent Drug and Subpotent Drug: potency failures obtained

Class IIModerate

FDANov 18, 2024Nationwide• Viatris Inc

Clonazepam Orally Disintegrating 0.125mg (Endo) – Labeling Error (2024)

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.

FDANov 18, 2024Nationwide• Endo USA, Inc.

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

Superpotent Drug and Subpotent Drug: potency failures obtained

Class IIModerate

FDANov 18, 2024Nationwide• Viatris Inc

Levothyroxine Sodium Tablets 25 mcg (Viatris) – Potency Failures (2024)

Superpotent Drug and Subpotent Drug: potency failures obtained

Class IIModerate

FDANov 18, 2024Nationwide• Viatris Inc

Levothyroxine Sodium Tablets 137 mcg (Viatris) – Potency Failures (2024)

Superpotent Drug and Subpotent Drug: potency failures obtained

Class IIModerate

FDANov 18, 2024Nationwide• Viatris Inc

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

Superpotent Drug and Subpotent Drug: potency failures obtained

Class IIModerate

FDANov 18, 2024Nationwide• Viatris Inc

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