Recalls / Class II
Class IID-0919-2017
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
- Affected lot / code info
- Lots: 052915-1, 052915-2, exp 5/5/2017
Why it was recalled
cGMP Deviations; lack of quality assurance.
Recalling firm
- Firm
- American Pharmaceutical Ingredients LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 6650 Highland Rd Ste 302, N/A, Waterford, Michigan 48327-1665
Distribution
- Quantity
- 1g=1 bottle; 5g=4 bottle; 25g=3 bottles
- Distribution pattern
- NY, GA, NV, CA, KY, TX
Timeline
- Recall initiated
- 2017-04-17
- FDA classified
- 2017-06-15
- Posted by FDA
- 2017-06-21
- Terminated
- 2018-05-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0919-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.