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Showing 581–600 of 2326 results

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Cura Hongos Antifungal Cream (Kenil) – CGMP Deviation (2025)

CGMP Deviations

Class IIModerate

FDAApr 24, 2025DE, NC• KENIL HEALTHCARE PRIVATE LIMITED

Nature Mint Toothpaste (Kenil) – CGMP Deviation (2025)

CGMP Deviations

Class IIModerate

FDAApr 24, 2025DE, NC• KENIL HEALTHCARE PRIVATE LIMITED

CURA HONGOS Antifungal (Kenil Healthcare) - CGMP Issues (2025)

CGMP Deviations

Class IIModerate

FDAApr 24, 2025DE, NC• KENIL HEALTHCARE PRIVATE LIMITED

Nature Mint Toothpaste (Kenil) – CGMP Deviation (2025)

CGMP Deviations

Class IIModerate

FDAApr 24, 2025DE, NC• KENIL HEALTHCARE PRIVATE LIMITED

Rapidol Antibiotic Ointment (Kenil Healthcare) - CGMP Issues (2025)

CGMP Deviations

Class IIModerate

FDAApr 24, 2025DE, NC• KENIL HEALTHCARE PRIVATE LIMITED

19th Hole Snack Mix (Better Business Foods) – undeclared nuts (2025)

Undeclared Allergen

Contains undeclared almonds & undeclared sesame

Class IIModerate

FDAApr 23, 2025NY• Better Business...Better Foods, Inc.

Kumquat Slices (President Brand) – undeclared sulfites (2025)

Undeclared Allergen

Product contains undeclared sulfites (7.49mg/serving)

Class IIModerate

FDAApr 23, 2025MD, NJ, NY +1 more• East CK Trading Inc.

Polyvinyl Alcohol Eye Drops (BRS Analytical) - Sterility Concern (2025)

cGMP deviations and lack of assurance of sterility.

Class IIModerate

FDAApr 23, 2025Nationwide• BRS Analytical Services, LLC

Lubricant Eye Drops (BRS Analytical) - Sterility Concern (2025)

cGMP deviations and lack of assurance of sterility.

Class IIModerate

FDAApr 23, 2025Nationwide• BRS Analytical Services, LLC

Carboxymethylcellulose Eye Gel (BRS Analytical) - Sterility Concern (2025)

cGMP deviations and lack of assurance of sterility.

Class IIModerate

FDAApr 23, 2025Nationwide• BRS Analytical Services, LLC

Artificial Tears Solution (BRS Analytical) - Sterility Concern (2025)

cGMP deviations and lack of assurance of sterility.

Class IIModerate

FDAApr 23, 2025Nationwide• BRS Analytical Services, LLC

Carboxymethylcellulose Eye Solution (BRS Analytical) - Sterility Concern (2025)

cGMP deviations and lack of assurance of sterility.

Class IIModerate

FDAApr 23, 2025Nationwide• BRS Analytical Services, LLC

Clindamycin HCl Capsules (RemedyRePack) - CGMP Issues (2025)

CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.

Class IIModerate

FDAApr 22, 2025FL, PA, VA• RemedyRePack Inc.

Tirofiban Hydrochloride Injection (Eugia US) - Stability Concern (2025)

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

Class IIModerate

FDAApr 21, 2025Nationwide• Eugia US LLC

EVENITY Injection (Mckesson) - Temperature Excursion (2025)

CGMP Deviations; potential temperature excursions due to transit delays

Class IIModerate

FDAApr 21, 2025FL, OH, VA• Mckesson Medical-Surgical Inc. Corporate Office

BENLYSTA Injection (Mckesson) - Temperature Excursion (2025)

CGMP Deviations; potential temperature excursions due to transit delays

Class IIModerate

FDAApr 21, 2025FL, OH, VA• Mckesson Medical-Surgical Inc. Corporate Office

PROLIA Injection (Mckesson) - Temperature Excursion (2025)

CGMP Deviations; potential temperature excursions due to transit delays

Class IIModerate

FDAApr 21, 2025FL, OH, VA• Mckesson Medical-Surgical Inc. Corporate Office

Tirofiban Hydrochloride Injection (Eugia US) - Stability Concern (2025)

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

Class IIModerate

FDAApr 21, 2025Nationwide• Eugia US LLC

niCARdipine Hydrochloride Injection (American Regent) - Sterility Risk (2025)

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

Class IIModerate

FDAApr 18, 2025Nationwide• American Regent, Inc.

niCARdipine Hydrochloride Injection (American Regent) - Sterility Risk (2025)

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

Class IIModerate

FDAApr 18, 2025Nationwide• American Regent, Inc.

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