FDA-Drug2017-06-21Class II
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
American Pharmaceutical Ingredients LLC
Hazard
cGMP Deviations; lack of quality assurance.
Sold states
NY, GA, NV, CA, KY, TX
Affected count
1g=1 bottle; 5g=4 bottle; 25g=3 bottles
Manufactured in
6650 Highland Rd Ste 302, N/A, Waterford, MI, United States
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 American Pharmaceutical Ingredients, LLC, 6650 Highland Road, Waterford, MI 48327
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0919-2017Don't want to check this manually?
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