Drug 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
D-0919-2017
Product summary
- Event
- Event 77465
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1g=1 bottle; 5g=4 bottle; 25g=3 bottles
- Official record key
drug-enforcement:D-0919-2017
Official wording
Reason: cGMP Deviations; lack of quality assurance.
Code information: Lots: 052915-1, 052915-2, exp 5/5/2017
Distribution pattern: NY, GA, NV, CA, KY, TX
Derived failure modes
-
Manufacturing or process control
cGMP Deviations