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Showing 3241–3260 of 11714 results

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Fruit Basket (Cal Yee) – undeclared almonds (2024)

Undeclared Allergen

Undeclared almonds

Class IIModerate

FDADec 6, 2024AZ, CA, NM +6 more• Cal Yee Farm LLC

New Orleans Hot Mix (Cal Yee) – undeclared allergens (2024)

Undeclared Gluten

Undeclared wheat, Undeclared soybean oil

FDADec 6, 2024AZ, CA, NM +6 more• Cal Yee Farm LLC

Dark Chocolate Walnuts (Cal Yee) – undeclared milk (2024)

Undeclared Milk

Undeclared milk

Class IHigh

FDADec 6, 2024AZ, CA, NM +6 more• Cal Yee Farm LLC

Dark Chocolate Raisins (Cal Yee) – undeclared milk (2024)

Undeclared Milk

Undeclared milk

FDADec 6, 2024AZ, CA, NM +6 more• Cal Yee Farm LLC

Duloxetine Capsules 60mg (Amerisource) – CGMP Impurity Limit (2024)

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

Class IIModerate

FDADec 6, 2024Nationwide• Amerisource Health Services LLC

Duloxetine Capsules 30mg (Amerisource) – CGMP Impurity Limit (2024)

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

Class IIModerate

FDADec 6, 2024Nationwide• Amerisource Health Services LLC

Duloxetine Capsules 60mg (Amerisource) – CGMP Impurity Limit (2024)

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

Class IIModerate

FDADec 6, 2024Nationwide• Amerisource Health Services LLC

Duloxetine Capsules 30mg (Breckenridge) – CGMP Impurity Limit (2024)

CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Class IIModerate

FDADec 6, 2024Nationwide• Breckenridge Pharmaceutical, Inc

Duloxetine Capsules 30mg (Amerisource) – CGMP Impurity Limit (2024)

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

Class IIModerate

FDADec 6, 2024Nationwide• Amerisource Health Services LLC

Nebivolol Tablets 2.5mg (Aurobindo) – Nitrosamine Impurity (2024)

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.

Class IIModerate

FDADec 6, 2024Nationwide• Aurobindo Pharma USA Inc

Duloxetine Capsules 60mg (Breckenridge) – CGMP Impurity Limit (2024)

CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Class IIModerate

FDADec 6, 2024Nationwide• Breckenridge Pharmaceutical, Inc

Cajun Sesame Hot Sticks (Cal Yee) – undeclared allergens (2024)

Undeclared Gluten

Undeclared wheat, Undeclared soybean oil

FDADec 6, 2024AZ, CA, NM +6 more• Cal Yee Farm LLC

Dried Mangos with Chili (Cal Yee) – undeclared color (2024)

Undeclared Allergen

Undeclared yellow #5

Class IIModerate

FDADec 6, 2024AZ, CA, NM +6 more• Cal Yee Farm LLC

Dark Chocolate Almonds (Cal Yee) – undeclared milk (2024)

Undeclared Milk

Undeclared milk

FDADec 6, 2024AZ, CA, NM +6 more• Cal Yee Farm LLC

Temporary Titanium Abutments (DDS Lab) – Incorrect Implant Component (2024)

Certain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium abutment, which may lead the titanium abutment fracture, which may risk loosening of the affixed restoration; fragments could also injure oral mucosa, and could be aspirated.

FDADec 6, 2024Nationwide• DDS Lab

Dark Chocolate Apricots (Cal Yee) – undeclared milk (2024)

Undeclared Milk

Undeclared milk

FDADec 6, 2024AZ, CA, NM +6 more• Cal Yee Farm LLC

Butter Toffee Almonds (Cal Yee) – undeclared milk (2024)

Undeclared Milk

Undeclared milk

Class IIModerate

FDADec 6, 2024AZ, CA, NM +6 more• Cal Yee Farm LLC

Yogurt Coated Almonds (Cal Yee) – undeclared milk (2024)

Undeclared Milk

Undeclared milk

FDADec 6, 2024AZ, CA, NM +6 more• Cal Yee Farm LLC

Dialyzer Optiflux 160NRe (Fresenius) – Internal Blood Leak Risk (2024)

Potential for internal blood leaks due to cracked polyurethane

FDADec 5, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Timolol Maleate Solution (FDC) – Defective Container (2024)

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

Class IIModerate

FDADec 5, 2024IN, NJ• FDC Limited

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