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Showing 1301–1320 of 29086 results

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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 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

Levothyroxine Sodium 50mcg Tablets (Viatris) – Potency Variation (2024)

Superpotent Drug and Subpotent Drug: potency failures obtained

Class IIModerate

FDANov 18, 2024Nationwide• Viatris Inc

Levothyroxine Sodium Tablets 75 mcg (Viatris) – Potency Failures (2024)

Superpotent Drug and Subpotent Drug: potency failures obtained

Class IIModerate

FDANov 18, 2024Nationwide• Viatris Inc

Levothyroxine Sodium Tablets 175 mcg (Viatris) – Potency Failures (2024)

Superpotent Drug and Subpotent Drug: potency failures obtained

Class IIModerate

FDANov 18, 2024Nationwide• Viatris Inc

Impossible Spicy Sausage (Impossible Foods) – Metal pieces (2024)

product may contain pieces of metal

Class IIModerate

FDANov 15, 2024Nationwide• Impossible Foods 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.

Impossible Savory Sausage (Impossible Foods) – Metal pieces (2024)

product may contain pieces of metal

Class IIModerate

FDANov 15, 2024Nationwide• Impossible Foods Inc

Chicken Salad Sandwich (7-Eleven) – Mislabeled tuna (2024)

Tuna salad sandwiches were labeled as chicken salad sandwiches.

Class IIModerate

FDANov 15, 2024MN• Northern Tier Bakery LLC

L'Oven Fresh Keto Multiseed Tortillas (Rise Baking) – Metal Contamination (2024)

Foreign Material (metal)

Class IIModerate

FDANov 14, 2024CT, KS, MN +2 more• Rise Baking Company, LLC dba The New French Bakery Inc.

L'Oven Fresh Keto Original Tortillas (Rise Baking) – Metal Contamination (2024)

Foreign Material (metal)

Class IIModerate

FDANov 14, 2024CT, KS, MN +2 more• Rise Baking Company, LLC dba The New French Bakery Inc.

Duloxetine Capsules 30 mg (Amerisource) – Impurity Concern (2024)

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

Class IIModerate

FDANov 14, 2024OH, PA, PR• Amerisource Health Services LLC

Kirkland Severe Cold & Flu (LNK) – Quality Control Issue (2024)

CGMP Deviations: Released product should have been rejected.

Class IIModerate

FDANov 14, 2024Nationwide• LNK International, Inc.

Duloxetine Capsules 60 mg (Amerisource) – Impurity Concern (2024)

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

Class IIModerate

FDANov 14, 2024OH, PA, PR• Amerisource Health Services LLC

Duloxetine Capsules (Amerisource) – Impurity Limit Exceeded (2024)

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

Class IIModerate

FDANov 14, 2024OH, PA, PR• Amerisource Health Services LLC

Gelato Benzocaine Topical Gel (Keystone) – Manufacturing 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

Benzo-Jel Topical Anesthetic Gel (Keystone) – Manufacturing 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

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