Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
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.
FDA Drug Recalls
411 recalls · Class II, newest first
Class II · Moderate risk
Duloxetine DR Capsules USP 60 mg
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules USP 20 mg
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules USP 30 mg
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk
Progesterone Injection USP
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Class II · Moderate risk
First Aid Beauty Ultra Repair Cream
CGMP Deviations; product intended for quarantine was inadvertently distributed
Class II · Moderate risk
Cardura XL
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Class II · Moderate risk
Cardura XL
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Class II · Moderate risk
Levothyroxine Sodium Tablets
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
phenylephrine in 0.9% Sodium Chloride Inj
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
ketamine inj 50 mg per 1 mL
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
Colchicine Capsules 0.6 mg
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Class II · Moderate risk
medroxyPROGESTERone Acetate Injectable Suspension
CGMP Deviations
Class II · Moderate risk
glipiZIDE
Failed Dissolution Specifications:
Class II · Moderate risk
Ciprofloxacin Ophthalmic Solution USP
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
Clobazam Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Dabigatran Etexilate
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Class II · Moderate risk
Dabigatran Etexilate
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Class II · Moderate risk
chlorproMAZINE Hydrochloride Tablets
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Class II · Moderate risk
chlorproMAZINE Hydrochloride Tablets
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Class II · Moderate risk
Dapsone Gel 7.5%
Crystallization
Class II · Moderate risk
Dapsone Gel 7.5%
Crystallization
Class II · Moderate risk
PROFESSIONAL Regener-Eyes
Lack of Sterility Assurance
Class II · Moderate risk
LITE Regener-Eyes
Lack of Sterility Assurance
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.