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
Reported: June 21, 2017 Initiated: April 17, 2017 #D-0919-2017
Product Description
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.
Details
- Recalling Firm
- American Pharmaceutical Ingredients LLC
- Units Affected
- 1g=1 bottle; 5g=4 bottle; 25g=3 bottles
- Distribution
- NY, GA, NV, CA, KY, TX
- Location
- Waterford, MI
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by American Pharmaceutical Ingredients LLC. Units affected: 1g=1 bottle; 5g=4 bottle; 25g=3 bottles.
Why was this product recalled? ▼
cGMP Deviations; lack of quality assurance.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 21, 2017. Severity: Moderate. Recall number: D-0919-2017.
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