Class II · Moderate risk Ongoing
Amlodipine
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
FDA Drug Recalls
17,898 recalls, newest first
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.
Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets 5 mg/160 mg
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk Terminated
Infants' Ibuprofen
Reason Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Class II · Moderate risk Terminated
Infants' Ibuprofen
Reason Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Class II · Moderate risk Terminated
infants* IBUPROFEN
Reason Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Class III · Low risk Terminated
Norepinephrine 8 mg
Reason Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan and Hydrochlorothiazide Tablets
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan Tablets
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan Tablets
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan Tablets
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan Tablets
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class II · Moderate risk Terminated
Germ Bloc Health Hand Sanitizer Foam
Reason Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product
Class II · Moderate risk Terminated
Human Chorionic Gonadotropin 3000 IU
Reason Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
FastStat Topical Hemostat Introductory Kit
Reason cGMP violations noted during the firm's most recent inspection.
Class II · Moderate risk Terminated
BeeGentle Honey Flavored Topical Anesthetic
Reason cGMP violations noted during the firm's most recent inspection.
Class II · Moderate risk Terminated
SHEER DesenZ Desensitizing Treatment
Reason cGMP violations noted during the firm's most recent inspection.