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.
Recall initiated: 20170417
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated