Class II · Moderate risk Terminated
Lidocaine gel 2%
Reason Lack of sterility assurance.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Hydroxyprogesterone liquid
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
HCG liquid
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Glutathione liquid
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Epinephrine liquid 1:1000
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Cyclosporin liquid 2%
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Cefdinir for Oral Suspension USP
Reason CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Class II · Moderate risk Terminated
Cefdinir for Oral Suspension USP
Reason CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Class II · Moderate risk Terminated
0.9% Buffered Lidocaine HCl
Reason Subpotent
Class II · Moderate risk Terminated
Cidofovir Injection 375mg/5mL
Reason Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
Class II · Moderate risk Terminated
Dianeal Low Calcium
Reason Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
Class II · Moderate risk Ongoing
Valsartan Tablets USP 160 mg
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 USP 80 mg
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 USP 40 mg
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 USP 10mg/160mg
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 USP 320 mg
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 USP 320 mg
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk Ongoing
Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk Ongoing
Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk Ongoing
Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk Ongoing
Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk Ongoing
Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets USP 5 mg/320 mg
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets USP 10 mg/160 mg
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.