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Showing 521–540 of 1639 results

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FOUZEE SugarLin Herbal Capsules (Shoppers-Plaza) – Undeclared Medications (2024)

Undeclared Allergen

Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide

FDADec 16, 2024Nationwide• SHOPPERS- PLAZA

Ciprofloxacin Ophthalmic Solution (FDC Limited) – 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 16, 2024Nationwide

• FDC Limited

Clobazam Tablets (Amerisource) – Foreign Tablet Contamination (2024)

Presence of Foreign Tablets/Capsules

Class IIModerate

FDADec 13, 2024Nationwide• Amerisource Health Services LLC

Acetaminophen Tablets (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Acetaminophen Extra Strength 500mg 1000ct (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Nhan Sam Tuyet Lien Capsules (Buy-Herbal) – Undeclared Medications (2024)

Undeclared Allergen

Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine

FDADec 12, 2024Nationwide• Buy-Herbal

Diphenhydramine HCl 50mg (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Dabigatran Etexilate 75mg (Ascend) – Impurity Limit Exceeded (2024)

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

Class IIModerate

FDADec 12, 2024Nationwide• Ascend Laboratories, LLC

Diphenhydramine HCl 25mg 100ct (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Diphenhydramine HCl 25mg (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Dabigatran Etexilate 150mg (Ascend) – Impurity Limit Exceeded (2024)

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

Class IIModerate

FDADec 12, 2024Nationwide• Ascend Laboratories, LLC

Acetaminophen Regular Strength (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Acetaminophen Extra Strength 500mg (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

VidaSlim 90-day (Vidaslim Co.) – toxic yellow oleander (2024)

Due to the presence of Toxic yellow oleander

FDADec 11, 2024Nationwide• Vidaslim Co.

Chlorpromazine Tablets 25mg (Glenmark) – Impurity Limit Exceeded (2024)

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

Class IIModerate

FDADec 11, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Chlorpromazine Tablets 10mg (Glenmark) – Impurity Limit Exceeded (2024)

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

Class IIModerate

FDADec 11, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Dapsone Gel 7.5% (VIONA) – Crystallization Issue (2024)

Crystallization

Class IIModerate

FDADec 10, 2024Nationwide• VIONA PHARMACEUTICALS INC

Dapsone Gel 7.5% (Viona) – Crystallization (2024)

Crystallization

Class IIModerate

FDADec 10, 2024Nationwide• VIONA PHARMACEUTICALS INC

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

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