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Showing 1221–1240 of 29086 results

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Holiday Sprinkles Granola Mini Bars (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

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

Undeclared Allergen

Undeclared almonds

Class IIModerate

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

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

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

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

Diced Bartlett Pears (Pacific Coast Producers) – Foreign Objects (2024)

Potential contamination with foreign objects.

Class IIModerate

FDADec 5, 2024KY, MI, OH +1 more• Pacific Coast Producers

Daily 30+ Prebiotic Blend (Zoe) – Foreign Objects (2024)

Product may contain foreign objects: small metal pieces and/or stones

Class IIModerate

FDADec 4, 2024AZ, CA, CO +23 more• Zoe US, Inc.

Duloxetine Capsules 30mg (PD-Rx) – Nitrosamine Impurity (2024)

CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit

Class IIModerate

FDADec 4, 2024FL, MS, WI• PD-Rx Pharmaceuticals, Inc.

Nitrofurantoin Capsules 100mg (AvKARE) – Dissolution Failure (2024)

Failed Dissolution Specifications

Class IIModerate

FDADec 4, 2024Nationwide• AvKARE

Organic Pecan Halves (Pecan Star) – Undeclared Walnuts (2024)

Undeclared Allergen

Undeclared walnuts

Class IIModerate

FDADec 4, 2024AL, FL, GA +5 more• Pecan Star & Nut Corp.

Donor Human Milk (MN Milk Bank) – Foreign Material (2024)

Foreign material. (undetermined)

Class IIModerate

FDADec 3, 2024MN• Minnesota Milk Bank for Babies

Jalapeno Cheese Puffs (Wegmans) – Undeclared Ingredients (2024)

Undeclared Allergen

Undeclared monosodium glutamate, sodium diacetate, disodium inosinate and disodium guanylate, and spice extract

Class IIModerate

FDADec 3, 2024NY• Herr Foods Inc

Golden Bavarian Creme Filling (BakeMark) – pH Deviation (2024)

Scheduled process deviation: Final pH of 4.61, 4.66, 4.69, 4.67.

Class IIModerate

FDADec 3, 2024AL, FL, GA +19 more• BakeMark USA LLC.

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