Class II · Moderate risk Terminated
Estrone 5mg/mL Oil Injection
Reason Lack of sterility assurance.
Estrone Micronized
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations; lack of quality assurance.
What was recalled
Estrone Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-003-04) (NDC 44132-003-02)(NDC 44132-003-06)
- Recalling firm
- Qinhuangdao Zizhu Pharmaceutical, Co.
- NDC code
- 44132-003-04
- Origin
- N/A, China
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0657-2017
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 for prescription compounding
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
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
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