Estrone Micronized — Class II drug recall D-0657-2017
Terminated recall by Qinhuangdao Zizhu Pharmaceutical, Co., reported 2017-04-19, distributed in CO, MN, NJ, NY, SC, TX. cGMP Deviations; lack of quality assurance.
| Recall number | D-0657-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qinhuangdao Zizhu Pharmaceutical, Co., Qinhuangdao, N/A, China |
| Recall initiated | 2017-03-24 |
| Classified | 2017-04-11 |
| Reported by FDA | 2017-04-19 |
| Terminated | 2018-07-03 |
| Distributed | CO, MN, NJ, NY, SC, TX |
| Reason classes | cgmp |
| NDC | 44132-0003-02, 44132-0003-04, 44132-0003-06 |
| Lot numbers | 82801505001, 82801606001 |
| Expiration dates | 2017-05-04 |
Product
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)
Reason for recall
cGMP Deviations; lack of quality assurance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0657-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.