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Showing 2081–2100 of 29086 results

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International Bread Pita Chips – Incomplete Wheat Labeling (2024)

Label declares flour as an ingredient but does not declare sub-ingredients (wheat).

Class IIModerate

FDAApr 5, 2024CA• INTERNATIONAL PITA BREAD, INC.

International Bread Pita Chips – Incomplete Wheat Labeling (2024)

Label declares flour as an ingredient but does not declare sub-ingredients (wheat).

Class IIModerate

FDAApr 5, 2024CA• INTERNATIONAL PITA BREAD, INC.

Johnny's Parmesan Garlic Seasoning (OS Holding) – Undeclared Sesame (2024)

Undeclared Allergen

Undeclared Sesame. Johnny's Salad & Pasta Elegance product was mislabeled as Johnny's Parmesan Garlic Seasoning. The Johnny's Parmesan Garlic label did not declare sesame, but sesame seeds are visible through a clear plastic bottle.

Class IIModerate

FDAApr 5, 2024AK, ID, IN +7 more• OS Holding Inc

Bizcocho de Boda Puertorrique¿o Naked (Reposteria Artesanal Laura) – Undeclared Colors (2024)

Failure to declare FD&C Red #40, Red #3,Yellow #5, Yellow #6, Blue #1 and Blue #2

Class IIModerate

FDAApr 3, 2024IN, PR• Reposteria Artesanal Laura

Family Size Garden Salad (Taylor Farms) – Mislabeled Allergens (2024)

Undeclared Allergen

On 03/30, TFSW ALBSWY CHICKEN CAESAR SALAD 10OZ (Egg, F-Anchovy, Milk, Soy, Wheat) was mislabeled with undeclared allergens as ALBSWY GARDEN SALAD 17OZ (Milk, Wheat)

Class IIModerate

FDAApr 2, 2024AZ, CO, IN +4 more• Taylor Farms Southwest, Inc

Pink Lemonde (Charles Boggini) – Undeclared Red Color (2024)

Undeclared Allergen

Products contain undeclared FD&C Red No. 40

Class IIModerate

FDAMar 29, 2024AZ, CA, CT +6 more• Charles Boggini Company Llc

Cola Flavoring Base (Charles Boggini) – Undeclared Sulfites (2024)

Undeclared Allergen

Products contain undeclared sulfites.

Class IIModerate

FDAMar 29, 2024AZ, CA, CT +6 more• Charles Boggini Company Llc

Eyesaline Saline Eyewash (Honeywell) – Manufacturing Deviation (2024)

CGMP Deviations

Class IIModerate

FDAMar 29, 2024Nationwide• HONEYWELL INC

Buffalo Chicken Party Tray (Taylor Farms) – Mislabeled Allergens (2024)

Undeclared Milk

Undeclared Milk, Wheat, & Soy due to incorrect ingredient label

Class IIModerate

FDAMar 29, 2024IN, OR, WA• Taylor Farms Northwest, LLC

Philadelphia Avo Roll (Geissler's) – Undeclared Milk (2024)

Undeclared Allergen

undeclared allergens (milk)

Class IIModerate

FDAMar 28, 2024CT, MA• Geissler's Supermarket

Isotretinoin 40mg Capsules (Teva) – Superpotent Drug (2024)

Superpotent Drug: The 3-month stability result for assay was found to be above specification limit

Class IIModerate

FDAMar 28, 2024Nationwide• Teva Pharmaceuticals USA, Inc

Macarons Party Edition (Lidl) – undeclared multiple allergens (2024)

Undeclared Gluten

Undeclared Wheat, Soy, Egg, Milk, Tree Nuts (foreign language labeling)

Class IIModerate

FDAMar 28, 2024DE, GA, IN +8 more• Lidl US TRADING

Lansoprazole Capsules (NATCO) – Manufacturing Deviation (2024)

CGMP Deviations

Class IIModerate

FDAMar 27, 2024Nationwide• NATCO Pharma Limited

Yellow Onion Rings (Pueblo Fruits) – botulinum risk (2024)

The firm did not complete a hazard analysis for potential C. botulinum growth and toxin production of its processing, storage and shipping of raw onions into vacuum sealed bags.

Class IIModerate

FDAMar 27, 2024NE, NM• Pueblo Fruits, Inc.

Frozen Cut Green Beans (Wegmans) – foreign object contamination (2024)

Product may contain foreign object that appears to be of rodent origin.

Class IIModerate

FDAMar 27, 2024NY, PA• NORTERA FOODS USA

All Purpose Flour (Food Club) – undeclared allergens (2024)

Undeclared Milk

undeclared milk, egg, and soy

Class IIModerate

FDAMar 26, 2024Nationwide• Shawnee Milling Company

Ipratropium-Albuterol Solution (Cipla) – Short Fill Issue (2024)

Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.

Class IIModerate

FDAMar 26, 2024Nationwide• Cipla USA, Inc.

Diltiazem Extended-Release Capsules (Glenmark) – Dissolution Failure (2024)

Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.

Class IIModerate

FDAMar 26, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Methylergonovine Tablets (Amneal) – Dissolution Failure (2024)

Failed Dissolution Specifications

Class IIModerate

FDAMar 25, 2024Nationwide• Amneal Pharmaceuticals of New York, LLC

Egg Salad Sandwich (Hearn Kirkwood) – undeclared fish (2024)

Undeclared Allergen

Tuna salad sandwich was mislabeled as an egg salad sandwich. There is an undeclared allergen of fish (Tuna).

Class IIModerate

FDAMar 23, 2024FL, IN, MD +8 more• The Coastal Companies DBA Hearn Kirkwood

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