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 drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,535 recalls, newest first.
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.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules USP
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules USP
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class II · Moderate risk
Nebivolol Tablets
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Class II · Moderate risk
Timolol Maleate 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
Nitrofurantoin Capsules
Failed Dissolution Specifications
Class II · Moderate risk
DULoxetine DR USP
CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit