Class II · Moderate risk
Basic Reset CBD Reset 750 True Full Spectrum Wintergreen
Marketed without an Approved NDA/ANDA
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Nuovi Firming Masque
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Basic Reset Nuovi Skin Toner
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Miracle Facelift Masque
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Basic Reset Earth Wash Cleaner and Personal Care
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Prasugrel Tablets 5 mg
Failed Dissolution Specification: Low out of specification dissolution results.
Class II · Moderate risk
AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx…
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx…
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class III · Low risk
Gatifloxacin Ophthalmic Solution 0.5%
Labeling: Incorrect or missing package insert.
Class III · Low risk
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension
Labeling: Incorrect or missing package insert.
Class III · Low risk
Bimatoprost Ophthalmic Solution 0.03%
Labeling: Incorrect or missing package insert.
Class III · Low risk
Isotretinoin Capsules
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Class II · Moderate risk
Viatrexx-ANS/CNS
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk
Viatrexx-Male+
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk
Viatrexx-Neuro
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk
Viatrexx-Hair
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk
Viatrexx-Facial
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk
Viatrexx-Intra-Cell
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk
Viatrexx-Relief +
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk
Viatrexx-Immunexx
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk
Viatrexx-Arthros
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk
Viatrexx-GI
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk
Viatrexx-Mesenchyme
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk
Viatrexx-Lymph 1
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk
Viatrexx-Prolo
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.