FDA Drug Class II — Moderate

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

Hazard

cGMP Deviations; lack of quality assurance.

Products

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 A
Brand
American Pharmaceutical Ingredients LLC
UPC
Lots: 052915-1, 052915-2, exp 5/5/2017

Units Affected

1g=1 bottle; 5g=4 bottle; 25g=3 bottles