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

Class IHigh

FDANov 18, 2024Nationwide• Endo USA, 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 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 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.

Class IHigh

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.

Class IHigh

FDANov 18, 2024Nationwide• Endo USA, 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.

Class IHigh

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

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

Superpotent Drug and Subpotent Drug: potency failures obtained

Class IIModerate

FDANov 18, 2024Nationwide• Viatris Inc

Lisinopril Tablets 10 mg (Evaric) – Metal Fragment Risk (2024)

Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.

Class IIModerate

FDANov 15, 2024Nationwide• Evaric Pharmaceuticals Inc.

Topical Anesthetic Gel (Keystone Industries) – CGMP Vessel Defect (2024)

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

Class IIModerate

FDANov 14, 2024Nationwide• Keystone Industries