Class II · Moderate risk Ongoing
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride
Reason Subpotent Drug
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
VistaPharm
Reason Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Class II · Moderate risk Ongoing
VistaPharm
Reason Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Class II · Moderate risk Ongoing
VistaPharm
Reason Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Class II · Moderate risk Ongoing
VistaPharm
Reason Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Class II · Moderate risk Ongoing
Duloxetine DR Capsules
Reason CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Class II · Moderate risk Ongoing
Lidocaine HCl Injection USP
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
fentaNYL Citrate
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Estradiol Gel
Reason Defective Container; packets were found to be either empty or partially full.
Class II · Moderate risk Ongoing
Gas-X
Reason Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Class II · Moderate risk Ongoing
cimzia
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Amlodipine and Olmesartan Medoxomil Tablets
Reason Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Class II · Moderate risk Ongoing
Vitamin B-Complex
Reason Presence of a Foreign Substance; black particles observed in liquid
Class II · Moderate risk Ongoing
Atomoxetine Capsules HCL
Reason Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Class II · Moderate risk Ongoing
Erythromycin Tablets
Reason CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Class II · Moderate risk Ongoing
Erythromycin Tablets
Reason CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Class II · Moderate risk Ongoing
Ascend Laboratories
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Oasis Tears PF
Reason Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
Class II · Moderate risk Ongoing
Liraglutide Injection
Reason Presence of particulate matter: a white thread-like structure in the cartridge
Class II · Moderate risk Ongoing
Octreotide Acetate for Injectable Suspension
Reason Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk Ongoing
Enalapril Maleate Tablets
Reason Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Class II · Moderate risk Ongoing
Similasan
Reason Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.