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Showing 321–340 of 1571 results

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Indomethacin Extended-Release Capsules (KVK Tech) – Manufacturing Deviation (2025)

cGMP deviations

Class IIModerate

FDAMay 9, 2025Nationwide• KVK Tech, Inc.

Phentermine Hydrochloride Capsules (KVK Tech) – Manufacturing Deviation (2025)

cGMP deviations

Class IIModerate

FDAMay 9, 2025Nationwide• KVK Tech, Inc.

Bromfenac Ophthalmic Solution (Alembic) – Impurity Specification Failure (2025)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAMay 7, 2025Nationwide• Alembic Pharmaceuticals Limited

Endurance Boost Capsules (EnShiShiXiangNi) – Undeclared Sildenafil (2025)

Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).

FDAMay 6, 2025Nationwide• EnShiShiXiangNiShangMaoYouXianGongSi

Testosterone Cypionate Injection (Empower Pharmacy) – Sterility Risk (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2025Nationwide• Empower Clinic Services, LLC dba Empower Pharmacy

Kids Multivitamin Gummies (Nordic Naturals) – Mislabeled Product (2025)

Product is mislabeled.

FDAMay 2, 2025AK, AZ, CA +17 more• Nordic Naturals, Inc.

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

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

Artridon Glucosamine (Kenil Healthcare) - CGMP Issues (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

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

CGMP Deviations

Class IIModerate

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

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

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

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