Class II · Moderate risk
Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem
CGMP Deviations: Presence of NDMA impurity detected in product.
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.
14,543 recalls, newest first.
Class II · Moderate risk
Estradiol Vaginal Inserts USP
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
Class II · Moderate risk
BIOGENYX True Full Spectrum CBD Oil Cinnamon
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
BIOGENYX True Full Spectrum CBD Oil Natural Flavor
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
BIOGENYX True Full Spectrum CBD Oil Wintergreen
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Basic Reset CBD Reset 2400
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. oz.
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Basic Reset CBD Reset 750 True Full Spectrum Cinnamon
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Basic Reset CBD Reset 750 True Full Spectrum Wintergreen
Marketed without an Approved NDA/ANDA
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 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.