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

FDA recall notice · announced June 21, 2017 · American Pharmaceutical Ingredients

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: NY, GA, NV, CA, KY, TX
Lot/code information: Lots: 052915-1, 052915-2, exp 5/5/2017
Quantity: 1g=1 bottle; 5g=4 bottle; 25g=3 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0919-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.