Class II · Moderate risk Ongoing
Regular Strength Zantac 75 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
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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
Regular Strength Zantac 150 mg
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
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 I · High risk Terminated
Green Lumber Natural Fuel For Men capsule
Reason Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.
Class II · Moderate risk Terminated
Estradiol Vaginal Inserts USP
Reason Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
Class III · Low risk Terminated
Atorvastatin Calcium Tablets
Reason Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
Class III · Low risk Terminated
PF-Succinylcholine Chloride Injection
Reason Incorrect labeling: Incorrect or missing lot and/or exp date
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