Class II · Moderate risk Ongoing
Lidocaine HCl injection
Reason Lack of Assurance of Sterility
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Lactated Ringer's Irrigation
Reason Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class II · Moderate risk Ongoing
0.9 % Sodium Chloride Irrigation
Reason Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class II · Moderate risk Ongoing
Dextrose Injection USP
Reason Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class II · Moderate risk Ongoing
Sterile Water for Injection USP
Reason Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class II · Moderate risk Ongoing
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
Reason cGMP deviations.
Class II · Moderate risk Ongoing
Ketamine Hydrochloride Injectable Solution
Reason cGMP deviations.
Class II · Moderate risk Ongoing
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
Reason cGMP deviations.
Class II · Moderate risk Ongoing
fentaNYL Citrate Injectable Solution
Reason cGMP deviations.
Class II · Moderate risk Ongoing
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride
Reason cGMP deviations.
Class II · Moderate risk Ongoing
fentaNYL Citrate Injectable Solution
Reason cGMP deviations.
Class II · Moderate risk Ongoing
Phenylephrine Hydrochloride Injectable Solution
Reason cGMP deviations.
Class II · Moderate risk Ongoing
Blemish Spot Treatment
Reason Failed Stability Specifications
Class II · Moderate risk Ongoing
EPINEPHRINE Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Prazosin Hydrochloride Capsules
Reason cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Class II · Moderate risk Ongoing
Prazosin Hydrochloride Capsules
Reason cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Class II · Moderate risk Ongoing
Prazosin Hydrochloride Capsules
Reason cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Class II · Moderate risk Ongoing
Pantoprazole Sodium
Reason Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Class II · Moderate risk Ongoing
Fluocinonide
Reason Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Class II · Moderate risk Ongoing
Fluocinonide
Reason Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Class II · Moderate risk Ongoing
Fluocinonide
Reason Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Class II · Moderate risk Ongoing
Artificial Tears Lubricant Eye Drops
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Memantine Hydrochloride Extended-Release
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
GE Healthcare Omnipaque
Reason Presence of particulate matter
Class II · Moderate risk Ongoing
GE Healthcare Omnipaque
Reason Presence of particulate matter