ESTRONE USP recalled over manufacturing violations

Recall date

April 17, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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-…

Recall number

D-0919-2017

FDA classification

Class II

Brand / firm

American Pharmaceutical Ingredients LLC

Sold / distributed

NY, GA, NV, CA, KY, TX

Why it was recalled

cGMP Deviations; lack of quality assurance.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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