Class II · Moderate risk
Estrone 5mg/mL Oil Injection
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.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
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)
Affected NDCs
44132-0003-02
44132-0003-04
44132-0003-06
Compare with the code on your package — it is the most precise check available.
Drug: Estrone
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Estrone NDC 44132-0003 |
1 kg/kg | Powder | Qinhuangdao Zizhu Pharmaceutical Co., Ltd. | BULK INGREDIENT |
- 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 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Estrone recalls
See all
Class II · Moderate risk
Estrone USP for prescription compounding
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
Estrone USP
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Estrone
cGMP Deviations: lack of quality assurance at the API manufacturer.
Class II · Moderate risk
Estrone
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Other recalls by Qinhuangdao Zizhu Pharmaceutical, Co.
All 2017 recalls
Class II · Moderate risk
Levonorgestrel Non-Micronized
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Ethinyl Estradiol Micronized
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Testosterone Micronized
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Estriol Micronized
cGMP Deviations; lack of quality assurance.
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