Class II · Moderate risk Ongoing
Regular Strength Zantac 150 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Regular Strength Zantac 75 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Maximum Strength Zantac 150 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Cool Mint Maximum Strength Zantac 150 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Regular Strength Zantac 150 mg Distributed by: Chattem
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Maximum Strength Zantac 150 mg Distributed by: Chattem
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Regular Strength Zantac 75 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Estradiol Vaginal Inserts USP
Reason Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
Class II · Moderate risk Terminated
BIOGENYX True Full Spectrum CBD Oil Cinnamon
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
BIOGENYX True Full Spectrum CBD Oil Natural Flavor
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
BIOGENYX True Full Spectrum CBD Oil Wintergreen
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
Basic Reset CBD Reset 2400
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. oz.
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
Basic Reset CBD Reset 750 True Full Spectrum Cinnamon
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
Basic Reset CBD Reset 750 True Full Spectrum Wintergreen
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
Nuovi Firming Masque
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
Basic Reset Nuovi Skin Toner
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
Miracle Facelift Masque
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
Basic Reset Earth Wash Cleaner and Personal Care
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
Prasugrel Tablets 5 mg
Reason Failed Dissolution Specification: Low out of specification dissolution results.
Class II · Moderate risk Terminated
AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx…
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Terminated
AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx…
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Terminated
Viatrexx-ANS/CNS
Reason Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk Terminated
Viatrexx-Male+
Reason Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.