Class II · Moderate risk Terminated
Soothe & Cool Protect Moisture Guard Skin Protectant
Reason GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Levoxyl
Reason Superpotent Drug.
Class II · Moderate risk Terminated
Fentanyl Citrate 2 mcg per mL
Reason Sub-potent
Class II · Moderate risk Terminated
Fentanyl Citrate 2 mcg per mL
Reason Sub-potent
Class II · Moderate risk Ongoing
Valsartan and Hydrochlorothiazide Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan and Hydrochlorothiazide Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan and Hydrochlorothiazide Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan and Hydrochlorothiazide Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan and Hydrochlorothiazide Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Terminated
Estradiol Tablets
Reason Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
Class II · Moderate risk Ongoing
Amlodipine
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk Ongoing
Amlodipine
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk Ongoing
Amlodipine
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk Ongoing
Amlodipine
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets 10 mg/320 mg
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets 5 mg/320 mg
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets 10 mg/160 mg
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.