FDAFDA · Food and drugs·Recall number D-0919-2017
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
Published June 21, 2017 · Recall initiated: April 17, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP Deviations; lack of quality assurance.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Distributor
- NY, GA, NV, CA, KY, TX
- Lot
- Lots: 052915-1, 052915-2, exp 5/5/2017
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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