Class II · Moderate risk
Regular Strength Zantac 150 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
FDA Drug Recalls
1,586 recalls · Class II, newest first
Class II · Moderate risk
Regular Strength Zantac 75 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Maximum Strength Zantac 150 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Cool Mint Maximum Strength Zantac 150 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Regular Strength Zantac 150 mg Distributed by: Chattem
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Maximum Strength Zantac 150 mg Distributed by: Chattem
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Regular Strength Zantac 75 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
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 · 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.