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Showing 4181–4200 of 68218 results

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Accutome Bipolar Pencil (Kirwan) – Tube Breakage Risk (2024)

Potential for the outer stainless-steel tube to break or detach.

FDANov 14, 2024Nationwide• Kirwan Surgical Products, LLC

Optikon Bipolar Pencil (Kirwan) – Tube Breakage Risk (2024)

Potential for the outer stainless-steel tube to break or detach.

FDANov 14, 2024Nationwide• Kirwan Surgical Products, 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

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

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

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

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