Class II
Terminated
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
- Recall Initiated
- April 17, 2017
- Posted
- June 21, 2017
- Recall Number
- D-0919-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1g=1 bottle; 5g=4 bottle; 25g=3 bottles
- Firm Location
- Waterford, MI, United States
Reason for Recall
cGMP Deviations; lack of quality assurance.
Distribution
NY, GA, NV, CA, KY, TX
Lot / Code Info
Lots: 052915-1, 052915-2, exp 5/5/2017
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