American Pharmaceutical Ingredients LLC recalls ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8
Recalled June 21, 2017 · FDA recall D-0919-2017 · American Pharmaceutical Ingredients
Hazard
cGMP Deviations; lack of quality assurance. · FDA Class II
Units
1g=1 bottle; 5g=4 bottle; 25g=3 bottles
Sold at
NY, GA, NV, CA, KY, TX
Description
cGMP Deviations; lack of quality assurance.
Product
ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Prescription Compounding, RX Only, Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC, 6650 Highland Road, Waterford, MI 48327
Manufacturer(s)
American Pharmaceutical Ingredients LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →