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Showing 621–640 of 14362 results

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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

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.

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

Esomeprazole Oral Suspension (Zydus) – Incorrect NDC Number (2024)

Labeling: Not Elsewhere Classified - Wrong NDC number

FDANov 14, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

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

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

Quala Dental 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

SensiCaine Ultra 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

Dental City 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

Health-Tec 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

Primo 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

Pearson Quality 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

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

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

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

Venofer Injection (American Regent) – Glass Delamination Risk (2024)

Presence of Particulate Matter: Potential for glass delamination from the vials.

Class IIModerate

FDANov 11, 2024Nationwide• American Regent, Inc.

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