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Showing 261–280 of 1310 results

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Testosterone Pellet 200 mg (BSO LLC) – Glass Particle Contamination (2025)

Presence of Particulate Matter: Glass particles were found in pellet vials.

Class IIModerate

FDAApr 28, 2025Nationwide• BSO LLC

Testosterone Pellet 100mg (BSO) – Particulate Matter Risk (2025)

Presence of Particulate Matter: Glass particles were found in pellet vials.

Class IIModerate

FDAApr 28, 2025Nationwide• BSO LLC

Testosterone Pellet 200mg (BSO) – Particulate Matter Risk (2025)

Presence of Particulate Matter: Glass particles were found in pellet vials.

Class IIModerate

FDAApr 28, 2025Nationwide• BSO LLC

Testosterone Pellet 200 mg (BSO LLC) – Glass Particle Contamination (2025)

Presence of Particulate Matter: Glass particles were found in pellet vials.

Class IIModerate

FDAApr 28, 2025Nationwide• BSO LLC

Infuvite Adult Vitamins (Mckesson) – Cold Chain Transit Delay (2025)

Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.

Class IIModerate

FDAApr 25, 2025FL, IN, MS• Mckesson Medical-Surgical Inc. Corporate Office

Medroxyprogesterone Acetate Injection (Mckesson) – Cold Chain Transit Delay (2025)

Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.

Class IIModerate

FDAApr 25, 2025FL, IN, MS• Mckesson Medical-Surgical Inc. Corporate Office

Optim V Anti-Itch Cream (Kenil Healthcare) - CGMP Issues (2025)

CGMP Deviations

Class IIModerate

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

Artridon Glucosamine (Kenil Healthcare) - CGMP Issues (2025)

CGMP Deviations

Class IIModerate

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

Kofal Pain Relief Ointment (Kenil) – CGMP Deviation (2025)

CGMP Deviations

Class IIModerate

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

Kofal Athletes Pain Relief (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

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.

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

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

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

Clindamycin Hydrochloride Capsules (Preferred Pharmaceuticals) - CGMP Issues (2025)

cGMP Deviations

Class IIModerate

FDAApr 18, 2025Nationwide• Preferred Pharmaceuticals, 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.

Timolol Maleate Eye Solution (FDC Limited) - Defective Container (2025)

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

FDAApr 18, 2025Nationwide• FDC Limited

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