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Showing 641–660 of 14362 results

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Venofer Injection (American Regent) – Glass Delamination Risk (2024)

Presence of Particulate Matter: Potential for glass delamination from the vials.

Class IIModerate

FDANov 11, 2024Nationwide• American Regent, Inc.

Venofer Injection (American Regent) – Glass Delamination Risk (2024)

Presence of Particulate Matter: Potential for glass delamination from the vials.

Class IIModerate

FDANov 11, 2024Nationwide• American Regent, Inc.

Aspirin Chewable Tablet (Safecor Health) – Packaging Defect (2024)

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

Class IIModerate

FDANov 11, 2024Nationwide• Safecor Health, LLC

Vitamin B1 Tablet (Safecor Health) – Packaging Defect (2024)

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

Class IIModerate

FDANov 11, 2024Nationwide• Safecor Health, LLC

Vitamin D3 Tablet (Safecor Health) – Packaging Defect (2024)

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

Class IIModerate

FDANov 11, 2024Nationwide• Safecor Health, LLC

Levothyroxine Sodium Tablets (Accord Healthcare) – Subpotent Drug (2024)

Subpotent drug

Class IIModerate

FDANov 8, 2024Nationwide• ACCORD HEALTHCARE, INC.

Cinacalcet Tablets (Aurobindo) – Impurity Limit Exceeded (2024)

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

Class IIModerate

FDANov 7, 2024Nationwide• Aurobindo Pharma USA Inc

Cinacalcet Tablets (Aurobindo) – Impurity Limit Exceeded (2024)

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

Class IIModerate

FDANov 7, 2024Nationwide• Aurobindo Pharma USA Inc

Guaifenesin Dextromethorphan Syrup (Harvard Drug Group) – Specification Failure (2024)

Failed Impurity/Degradation Specifications

Class IIModerate

FDANov 7, 2024Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Cinacalcet Tablets (Aurobindo) – Impurity Limit Exceeded (2024)

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

Class IIModerate

FDANov 7, 2024Nationwide• Aurobindo Pharma USA Inc

Trinity Gold Nutrition Capsules (Trinity Gold) – Undeclared Ingredients (2024)

Undeclared Allergen

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

Class IIModerate

FDANov 6, 2024Nationwide• Trinity Gold Nutrition

Bevacizumab Sterile Injection (Tailstorm Health) – Sterility Concern (2024)

Lack of Sterility Assurance

Class IIModerate

FDANov 6, 2024Nationwide• Tailstorm Health INC

OneMultivitaminic GAF-PLUS (Armonia) – Undeclared Drugs (2024)

Undeclared Allergen

Contains undeclared drugs Acetaminophen and Dexamethasone Phosphate, and the undeclared sweetener Aspartame

Class IIModerate

FDANov 6, 2024CA, FL, GA +9 more• Armonia Natural Store LLC

Hydralazine HCl Tablets (Major Pharmaceuticals) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications; during routine stability testing for impurities.

FDANov 5, 2024Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

PeakMax Capsules (Boulla) – Undeclared Ingredients (2024)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

FDANov 4, 2024Nationwide• Boulla LLC

ZapMax Capsules (Boulla) – Undeclared Ingredients (2024)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

FDANov 4, 2024Nationwide• Boulla LLC

VitalityXtra Capsules (Boulla) – Undeclared Ingredients (2024)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

FDANov 4, 2024Nationwide• Boulla LLC

ZoomMax Capsules (Boulla) – Undeclared Ingredients (2024)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

FDANov 4, 2024Nationwide• Boulla LLC

Diltiazem Hydrochloride Capsules 60mg (Glenmark) – Impurity Risk (2024)

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Class IIModerate

FDANov 1, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Diltiazem Hydrochloride Capsules 120mg (Glenmark) – Impurity Risk (2024)

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Class IIModerate

FDANov 1, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

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