Class II · Moderate risk Terminated
Cinnafresh anticavity gel toothpaste
Reason CGMP Deviations
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Rapidol
Reason CGMP Deviations
Class II · Moderate risk Terminated
Rapidol Maximum Strength
Reason CGMP Deviations
Class II · Moderate risk Terminated
Optim V
Reason CGMP Deviations
Class II · Moderate risk Terminated
Kofal
Reason CGMP Deviations
Class II · Moderate risk Terminated
KOFAL Original
Reason CGMP Deviations
Class II · Moderate risk Terminated
Kingskin
Reason CGMP Deviations
Class II · Moderate risk Terminated
Cura Hongos
Reason CGMP Deviations
Class II · Moderate risk Terminated
Cura Hongos
Reason CGMP Deviations
Class II · Moderate risk Terminated
Artridon Glucosamine
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Polyvinyl Alcohol Ophthalmic Solution 1.4%
Reason cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk Ongoing
Lubricant Eye Drops Solution
Reason cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk Ongoing
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
Reason cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk Ongoing
Carboxymethylcellulose Sodium Ophthalmic Gel 1%
Reason cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk Ongoing
Artificial Tears Ophthalmic Solution
Reason cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk Ongoing
Clindamycin HCl Capsule
Reason CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Class II · Moderate risk Ongoing
Benlysta
Reason CGMP Deviations; potential temperature excursions due to transit delays
Class II · Moderate risk Ongoing
Evenity
Reason CGMP Deviations; potential temperature excursions due to transit delays
Class II · Moderate risk Ongoing
Prolia
Reason CGMP Deviations; potential temperature excursions due to transit delays
Class II · Moderate risk Ongoing
Tirofiban Hydrochloride Injection 12.5 mg/250 mL
Reason Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Class II · Moderate risk Ongoing
Tirofiban Hydrochloride Injection 5 mg/100 mL
Reason Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Class II · Moderate risk Ongoing
Timolol Maleate Ophthalmic Solution USP
Reason 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 II · Moderate risk Ongoing
niCARdipine Hydrochloride Injection
Reason Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Class II · Moderate risk Ongoing
niCARdipine Hydrochloride Injection
Reason Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Class II · Moderate risk Ongoing
Clindamycin Hydrochloride Capsules
Reason cGMP Deviations