Reported Jun 21, 2017 · Terminated
ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC:…
American Pharmaceutical Ingredients LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Pharmaceutical Ingredients LLC · 6650 Highland Rd Ste 302 · Waterford, MI · 48327-1665
Is this the product you have?
- ESTRONE USP
- packaged in a) 1g bottle (NDC58597-8049-2)
- c) 5g bottle (NDC58597-8049-3)
- d) 25g bottle (NDC58597-8049-4), For Prescription Compounding, RX Only, Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC, 6650 Highland Road, Waterford, MI 48327
- Lot codes and dates
- Lots
052915-1052915-2exp 5/5/2017
- Lots
- Amount recalled
- 1g=1 bottle; 5g=4 bottle; 25g=3 bottles
Where it was sold
Why it was recalled
cGMP Deviations; lack of quality assurance.
This product could cause temporary or reversible health problems — stop using it.
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