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
FDA Drug Recalls
2,661 recalls, 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 III · Low risk Ongoing
Epinephrine Injection
Reason Failed Impurities/Degradations Specifications
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 III · Low risk Ongoing
Nicotine Transdermal System Patch
Reason Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Class I · High risk Ongoing
DOXOrubin Hydrochloride Liposome injection
Reason Presence of Particulate matter: Particulate matter identified as glass.
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 III · Low risk Ongoing
Busulfan Injection
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
Vitamin B-Complex
Reason Presence of a Foreign Substance; black particles observed in liquid
Class III · Low risk Ongoing
Primidone Tablets
Reason Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class III · Low risk Ongoing
Primidone Tablets
Reason Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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 I · High risk Ongoing
Lactated Ringer's Injection USP
Reason Presence of Particulate Matter.
Class II · Moderate risk Ongoing
Ascend Laboratories
Reason Failed Dissolution Specifications