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Showing 841–860 of 2326 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

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

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.

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

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

Class IIModerate

FDADec 2, 2024Nationwide• RemedyRepack Inc.

Cinacalcet Tablets 30mg (AvKARE) – Nitrosamine Impurity (2024)

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

Class IIModerate

FDANov 27, 2024Nationwide• AvKARE

Cinacalcet Tablets 90mg (AvKARE) – Nitrosamine Impurity (2024)

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

Class IIModerate

FDANov 27, 2024Nationwide• AvKARE

Cinacalcet Tablets 60mg (AvKARE) – Nitrosamine Impurity (2024)

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

Class IIModerate

FDANov 27, 2024Nationwide• AvKARE

Olanzapine Tablets 2.5mg (Macleods) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications

Class IIModerate

FDANov 25, 2024Nationwide• Macleods Pharmaceuticals Ltd

VCF Contraceptive Gel (Apothecus) – Assay Deviation (2024)

CGMP deviations: out of specifications for assay

Class IIModerate

FDANov 22, 2024Nationwide• Apothecus Pharmaceutical Corp.

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