Class II · Moderate risk Terminated
Estrone 5mg/mL Oil Injection
Reason Lack of sterility assurance.
Estrone USP for prescription compounding
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
What was recalled
Estrone USP for prescription compounding, packaged in a) 5 g (NDC 58597-8049-3); b) 100mg (NDC 58597-8049-1); c) 25 g (NDC 58597-8049-4), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Recalling firm
- American Pharmaceutical Ingredients LLC
- NDC code
- 58597-8049-3
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0491-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Estrone recalls
See all
Class II · Moderate risk Terminated
Estrone USP
Reason cGMP Deviations; lack of quality assurance.
Class II · Moderate risk Terminated
Estrone
Reason cGMP Deviations: lack of quality assurance at the API manufacturer.
Class II · Moderate risk Terminated
Estrone
Reason cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class II · Moderate risk Terminated
Estrone Micronized
Reason cGMP Deviations; lack of quality assurance.
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