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Showing 1341–1360 of 29086 results

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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

Docusate Sodium Softgel (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

Calcium Carbonate Chewable (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

Giant Eagle Butter Pecan Ice Cream – Undeclared Soy (2024)

Undeclared soy (soy lecithin).

Class IIModerate

FDANov 11, 2024IN, MD, OH +2 more• House Of Flavors, Inc.

Compass Minerals Bulk Salt – Foreign Material (2024)

foreign material

Class IIModerate

FDANov 9, 2024IN, MA, WI• Compass Minerals America Inc.

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

Subpotent drug

Class IIModerate

FDANov 8, 2024Nationwide• ACCORD HEALTHCARE, INC.

Organic Hot Agave (Cumberland) – Yeast Contamination (2024)

Elevated Osmophilic Yeast Count

Class IIModerate

FDANov 7, 2024AL, AZ, CA +16 more• Cumberland Packing Corp.

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

Boardwalk Antibacterial Handsoap Refill (Midlab) – Microbiological Contamination (2024)

cGMP Deviations: Out of specification results for micro in hand soap products.

Class IIModerate

FDANov 6, 2024Nationwide• Midlab Incorporated

Maxim Assure Antibacterial Soap (Midlab) – Microbiological Contamination (2024)

cGMP Deviations: Out of specification results for micro in hand soap products.

Class IIModerate

FDANov 6, 2024Nationwide• Midlab Incorporated

Germ Away Antibacterial Hand Soap (Midlab) – Microbiological Contamination (2024)

cGMP Deviations: Out of specification results for micro in hand soap products.

Class IIModerate

FDANov 6, 2024Nationwide• Midlab Incorporated

Array Liquid Antiseptic Handwash (Midlab) – Microbiological Contamination (2024)

cGMP Deviations: Out of specification results for micro in hand soap products.

Class IIModerate

FDANov 6, 2024Nationwide• Midlab Incorporated

Genuine Joe Antibacterial Lotion Soap (Midlab) – Microbiological Contamination (2024)

cGMP Deviations: Out of specification results for micro in hand soap products.

Class IIModerate

FDANov 6, 2024Nationwide• Midlab Incorporated

Compliance Dishwashing Liquid Soap (Midlab) – Microbiological Contamination (2024)

cGMP Deviations: Out of specification results for micro in hand soap products.

Class IIModerate

FDANov 6, 2024Nationwide• Midlab Incorporated

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

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