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Showing 2201–2220 of 29086 results

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Fruity Pebbles Popsicle (Frios) – Undeclared Yellow #5 (2024)

Undeclared Allergen

Undeclared Color Additives - Yellow #5

Class IIModerate

FDAFeb 7, 2024AL, AZ, CO +14 more• FGP Manufacturing, LLC

Plant Based Pizza (Pasta Oggi) – Undeclared Milk (2024)

Undeclared Milk

Undeclared milk

Class IIModerate

FDAFeb 7, 2024CA, IL, IN +1 more• Pasta Oggi Inc.

Terlivaz Injection (Mallinckrodt) – Shipping Temperature Issue (2024)

cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.

Class IIModerate

FDAFeb 6, 2024Nationwide• Mallinckrodt Hospital Products Inc.

Acthar Gel (Mallinckrodt) – Shipping Temperature Issue (2024)

cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.

Class IIModerate

FDAFeb 6, 2024Nationwide• Mallinckrodt Hospital Products Inc.

Voriconazole Oral Suspension (Lupin) – Labeling Error (2024)

Labeling: Incorrect or Missing Package Insert

Class IIModerate

FDAFeb 5, 2024IL, NJ, OH• Lupin Pharmaceuticals Inc.

Mesalamine Capsules (Sun Pharmaceutical) – Dissolution Failure (2024)

Failed Dissolution Specifications: Out of specification for dissolution.

Class IIModerate

FDAFeb 5, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Omeprazole Suspension (Bausch Health) – Subpotent Drug (2024)

Subpotent Drug: Out of specification for assay

Class IIModerate

FDAFeb 2, 2024Nationwide• Bausch Health Companies, Inc.

Spinach & Feta Croissant (Frothy Monkey) – Metal Fragments (2024)

Potential Foreign Material - Metal Fragments

Class IIModerate

FDAFeb 1, 2024AL, TN• Bakery by Frothy Monkey

Lansoprazole Capsules (NATCO Pharma) – Inadequate Sealing (2024)

CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.

Class IIModerate

FDAFeb 1, 2024Nationwide• NATCO Pharma Limited

Plain Croissant (Frothy Monkey) – Metal Fragments (2024)

Potential Foreign Material - Metal Fragments

Class IIModerate

FDAFeb 1, 2024AL, TN• Bakery by Frothy Monkey

Meta Psyllium Fiber Capsules (Procter & Gamble) – Illegible Label (2024)

Illegible Label

Class IIModerate

FDAFeb 1, 2024AL, AZ, AR +38 more• The Procter & Gamble Company

Chocolate Croissant (Frothy Monkey) – Metal Fragments (2024)

Potential Foreign Material - Metal Fragments

Class IIModerate

FDAFeb 1, 2024AL, TN• Bakery by Frothy Monkey

Dannon Plain Yogurt (Danone) – Sanitizer Contamination (2024)

Potential contamination with sanitizer

Class IIModerate

FDAFeb 1, 2024GA• DANONE US LLC

Coffee Bags (House of Coffee Beans) – Allergen Contact (2024)

potential allergen contact with almonds, pecans and coconut.

Class IIModerate

FDAFeb 1, 2024Nationwide• House of Coffee Beans, Inc

Ham & Cheese Croissant (Frothy Monkey) – Metal Fragments (2024)

Potential Foreign Material - Metal Fragments

Class IIModerate

FDAFeb 1, 2024AL, TN• Bakery by Frothy Monkey

Yellow Colby Cheese (Country Corner Dairy) – Pasteurization Issue (2024)

Product was made with a lack of proper pasteurization.

Class IIModerate

FDAFeb 1, 2024MD, VA• Country Corner Dairy, LLC

Yellow Cheddar Cheese (Country Corner Dairy) – Pasteurization Issue (2024)

Product was made with a lack of proper pasteurization.

Class IIModerate

FDAFeb 1, 2024MD, VA• Country Corner Dairy, LLC

Sizzling Colby Cheese (Country Corner Dairy) – Pasteurization Issue (2024)

Product was made with a lack of proper pasteurization.

Class IIModerate

FDAFeb 1, 2024MD, VA• Country Corner Dairy, LLC

White Cheddar Cheese (Country Corner Dairy) – Pasteurization Issue (2024)

Product was made with a lack of proper pasteurization.

Class IIModerate

FDAFeb 1, 2024MD, VA• Country Corner Dairy, LLC

White Colby Cheese (Country Corner Dairy) – Pasteurization Issue (2024)

Product was made with a lack of proper pasteurization.

Class IIModerate

FDAFeb 1, 2024MD, VA• Country Corner Dairy, LLC

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