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Showing 4521–4540 of 29086 results

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Lisinopril Tablets (RemedyRepack) – Foreign Substance Risk (2022)

Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.

Class IIModerate

FDASep 15, 2022AK, IN, PA• RemedyRepack Inc.

Sanitizing Hand Spray (Salon Technologies) – Chemical Contamination (2022)

GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

Class IIModerate

FDASep 14, 2022FL, WA• Salon Technologies International Inc

Coca-Cola Classic 12 FL OZ Can (Coca-Cola) – foreign matter contamination (2022)

The product contain foreign matter (metal particles).

Class IIModerate

FDASep 14, 2022TX• COCA COLA SOUTHWEST BEVERAGES LLC

Lisinopril Tablets (Lupin) – Foreign Substance Risk (2022)

Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.

Class IIModerate

FDASep 13, 2022Nationwide• Lupin Pharmaceuticals Inc.

Triamcinolone Acetonide Cream (Direct Rx) – Texture Complaint (2022)

CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.

Class IIModerate

FDASep 12, 2022GA, ID, IN• Direct Rx

Skincell Mole Corrector Serum (Justified Labs) – Unapproved Drug (2022)

Marketed Without An Approved NDA/ANDA; Unapproved new drug

Class IIModerate

FDASep 9, 2022Nationwide• Justified Laboratories

Skincell Mole Corrector Serum (Justified Labs) – Unapproved Drug (2022)

Marketed Without An Approved NDA/ANDA; Unapproved new drug

Class IIModerate

FDASep 9, 2022Nationwide• Justified Laboratories

Organic Cranberry Frontier Mix (Aurora Products) – Undeclared Peanuts (2022)

Undeclared Nuts

Product contains undeclared peanuts.

Class IIModerate

FDASep 7, 2022ME, MA, NH +2 more• Aurora Products, Inc.

Synergy Hand Sanitizer (Superior Glove) – Impurity Excess (2022)

CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.

Class IIModerate

FDASep 1, 2022Nationwide• SUPERIOR GLOVE WORKS, LTD.

Lidocaine Hydrochloride Jelly (Akorn) – Sterility Issue (2022)

cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.

Class IIModerate

FDAAug 31, 2022Nationwide• Akorn, Inc.

Sodium Chloride Ophthalmic Ointment (Akorn) – Sterility Issue (2022)

cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.

Class IIModerate

FDAAug 31, 2022Nationwide• Akorn, Inc.

ADHD Medication (Teva) – Strength Labeling Error (2022)

Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.

Class IIModerate

FDAAug 29, 2022Nationwide• Teva Pharmaceuticals USA Inc

Ready Meals Snow Crab Legs (Albertsons) – Undeclared Fish (2022)

Undeclared Allergen

Undeclared allergen; fish (anchovy)

Class IIModerate

FDAAug 29, 2022OR, WA• Albertsons Companies LLC

QUAD-MIX Injectable (Carolina Infusion) – Sterility Concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 26, 2022Nationwide• Carolina Infusion

TEST CYP/DHEA Injection (Carolina Infusion) – Sterility Concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 26, 2022Nationwide• Carolina Infusion

TEST CYP/PROP Injectable (Carolina Infusion) – Sterility Concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 26, 2022Nationwide• Carolina Infusion

QUAD-MIX Injectable (Carolina Infusion) – Sterility Concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 26, 2022Nationwide• Carolina Infusion

Semaglutide/Cyanocobalamin Injectable (Carolina Infusion) – Sterility Concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 26, 2022Nationwide• Carolina Infusion

TEST CYP Injectable (Carolina Infusion) – Sterility Concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 26, 2022Nationwide• Carolina Infusion

TRI-MIX Injectable (Carolina Infusion) – Sterility Concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 26, 2022Nationwide• Carolina Infusion

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