Class II · Moderate risk Ongoing
Inflectra
Reason cGMP Deviations: Product intended for quarantine was inadvertently distributed.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Duloxetine Delayed-Release Capsules USP
Reason CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
Class II · Moderate risk Ongoing
Granix
Reason Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Class II · Moderate risk Ongoing
babyganics
Reason Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Class II · Moderate risk Ongoing
Clobazam Tablets
Reason Presence of Foreign Tablets/Capsules
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets
Reason Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Class II · Moderate risk Ongoing
Duloxetine DR Capsules USP 60 mg
Reason CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules USP 20 mg
Reason CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules USP 30 mg
Reason CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk Ongoing
Progesterone Injection USP
Reason Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Class II · Moderate risk Ongoing
First Aid Beauty Ultra Repair Cream
Reason CGMP Deviations; product intended for quarantine was inadvertently distributed
Class II · Moderate risk Terminated
Cardura XL
Reason Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Class II · Moderate risk Terminated
Cardura XL
Reason Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Class II · Moderate risk Terminated
Levothyroxine Sodium Tablets
Reason Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Class II · Moderate risk Terminated
phenylephrine in 0.9% Sodium Chloride Inj
Reason Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Class II · Moderate risk Terminated
ketamine inj 50 mg per 1 mL
Reason Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Class II · Moderate risk Terminated
Colchicine Capsules 0.6 mg
Reason Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Class II · Moderate risk Ongoing
medroxyPROGESTERone Acetate Injectable Suspension
Reason CGMP Deviations
Class II · Moderate risk Terminated
glipiZIDE
Reason Failed Dissolution Specifications:
Class II · Moderate risk Ongoing
Ciprofloxacin 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
Clobazam Tablets
Reason Presence of Foreign Tablets/Capsules
Class II · Moderate risk Ongoing
Dabigatran Etexilate
Reason CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Class II · Moderate risk Ongoing
Dabigatran Etexilate
Reason CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.