FDA recall D-0919-2017

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

Reason for recall

cGMP Deviations; lack of quality assurance.

Distribution

NY, GA, NV, CA, KY, TX

Key facts

Status

Terminated

Initiation date

2017-04-17

Report date

2017-06-21

Termination date

2018-05-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waterford, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0919-2017