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Showing 941–960 of 2326 results

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Sunitinib Capsules 12.5mg (AvKARE) – Label Mix-Up (2024)

Labeling: Label Mix-Up

Class IIModerate

FDAOct 18, 2024Nationwide• AvKARE

Sunitinib Capsules 25mg (AvKARE) – Label Mix-Up (2024)

Labeling: Label Mix-Up

Class IIModerate

FDAOct 18, 2024Nationwide• AvKARE

Perio Maintenance Rinse (Keystone) – Subpotent Drug (2024)

Subpotent Drug

Class IIModerate

FDAOct 17, 2024Nationwide• Keystone Industries

OneLAX Docusate Sodium (Akron) – CGMP Deviation (2024)

CGMP Deviations

Class IIModerate

FDAOct 15, 2024Nationwide• Akron Pharma, Inc.

Kirkland Signature Butter (Continental Dairy) – Missing Milk Statement (2024)

Butter lists cream, but may be missing the Contains Milk statement.

Class IIModerate

FDAOct 11, 2024TX• CONTINENTAL DAIRY FACILITIES SOUTHWEST LLC

Kirkland Signature Butter (Continental Dairy) – Missing Milk Statement (2024)

Butter lists cream, but may be missing the Contains Milk statement.

Class IIModerate

FDAOct 11, 2024TX• CONTINENTAL DAIRY FACILITIES SOUTHWEST LLC

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

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Class IIModerate

FDAOct 10, 2024Nationwide• ACCORD HEALTHCARE, INC.

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

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Class IIModerate

FDAOct 10, 2024Nationwide• ACCORD HEALTHCARE, INC.

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

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Class IIModerate

FDAOct 10, 2024Nationwide• ACCORD HEALTHCARE, INC.

Cinacalcet Tablets 60mg (Dr. Reddy's) – Nitrosamine Impurity (2024)

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Class IIModerate

FDAOct 9, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Cinacalcet Tablets 90mg (Dr. Reddy's) – Nitrosamine Impurity (2024)

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Class IIModerate

FDAOct 9, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Cinacalcet Tablets 30mg (Dr. Reddy's) – Nitrosamine Impurity (2024)

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Class IIModerate

FDAOct 9, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

AK Forte Tablets (C & A) – Undeclared Ingredients (2024)

Undeclared Allergen

Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.

Class IIModerate

FDAOct 8, 2024Nationwide• C & A Naturistics

LICEOUT Treatment (Neogen) – CGMP Violation (2024)

CGMP violations.

Class IIModerate

FDAOct 8, 2024Nationwide• Neogen Corporation

LICEOUT Treatment (Neogen) – CGMP Violation (2024)

CGMP violations.

Class IIModerate

FDAOct 8, 2024Nationwide• Neogen Corporation

Apple Wedge Cider (Apple Wedge) – Elevated patulin (2024)

Patulin. Apple Cider was found to have elevated levels of patulin after receiving analytical testing results from 3rd party laboratory. Lab sample detected 78 ppb; limit is 50 ppb.

Class IIModerate

FDAOct 7, 2024FL, GA, NC +1 more• Apple Wedge LLC

Apple Wedge Cider (Apple Wedge LLC) – Elevated Patulin (2024)

Patulin. Apple Cider was found to have elevated levels of patulin after receiving analytical testing results from 3rd party laboratory. Lab sample detected 78 ppb; limit is 50 ppb.

Class IIModerate

FDAOct 7, 2024FL, GA, NC +1 more• Apple Wedge LLC

Apple Wedge Cider (Apple Wedge LLC) – Elevated Patulin (2024)

Patulin. Apple Cider was found to have elevated levels of patulin after receiving analytical testing results from 3rd party laboratory. Lab sample detected 78 ppb; limit is 50 ppb.

Class IIModerate

FDAOct 7, 2024FL, GA, NC +1 more• Apple Wedge LLC

Banana Pudding Mix (DYMA Brands) – Metal Fragment Risk (2024)

After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.

Class IIModerate

FDAOct 2, 2024AZ, AR, CA +27 more• DYMA BRANDS

Katy's Kitchen Lemon Gelatin Mix (DYMA Brands) – Metal Fragment Risk (2024)

After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.

Class IIModerate

FDAOct 2, 2024AZ, AR, CA +27 more• DYMA BRANDS

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