American Pharmaceutical Ingredients LLC

FDA Regulatory Profile

Summary

Total Recalls
71
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0592-2018Class IISermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10March 7, 2018
D-0591-2018Class IIOxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3March 7, 2018
D-0498-2018Class IIKetamine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8333-4); b) 100g (NDC 5February 9, 2018
D-0533-2018Class IIVardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8575-2); February 9, 2018
D-0482-2018Class IICyclosporine USP, for prescription compounding, packaged in a) 5g (NDC 58597-8210-2); b) 10g (NDC 58February 9, 2018
D-0509-2018Class IILiothyronine Sodium USP for prescription compounding ,1g, RX only, packed by American PharmaceuticaFebruary 9, 2018
D-0513-2018Class IINifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25g (NDC 5859February 9, 2018
D-0524-2018Class IITadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8538-2); b) February 9, 2018
D-0489-2018Class IIEstradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, packaged in a) 5g (NDC 58February 9, 2018
D-0523-2018Class IITacrolimus USP (Monohydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8029-4); b) February 9, 2018
D-0494-2018Class IIGabapentin USP for prescription compounding, packaged in a) 25g (NDC 58597-8014-4); b) 100g (NDC 5February 9, 2018
D-0493-2018Class IIFlurbiprofen USP for prescription compounding, packaged in a) 25g (NDC 58597-8075-4); b)100g (NDC 58February 9, 2018
D-0474-2018Class IIAmitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC 58597-8003-4); b) 100 February 9, 2018
D-0496-2018Class IIImiquimod USP for prescription compounding, packaged in a) 1g (NDC 58597-8317-1); b) 10g (NDC 58597-February 9, 2018
D-0526-2018Class IITestosterone Cypionate USP (Micronized) for prescription compounding, packaged in a)100g (NDC 58597February 9, 2018
D-0500-2018Class IIKetoprofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8336-4); b) February 9, 2018
D-0529-2018Class IITramadol HCl USP (CIV) for prescription compounding, packaged in a) 25g (NDC 58597-8032-4); b) 100gFebruary 9, 2018
D-0516-2018Class IIPhentolamine Mesylate USP for prescription compounding, packaged in a) 1g (NDC 58597-8077-3); b) 5g February 9, 2018
D-0520-2018Class IIStanozolol USP for prescription compounding, packaged in a) 25g (NDC 58597-8525-3);b)100g (NDC 58597February 9, 2018
D-0511-2018Class IINaltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8407-1); bFebruary 9, 2018