Estrone Micronized recalled over manufacturing violations
- Recall date
- March 24, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Qinhuangdao Zizhu Pharmaceutical, Co. recalls Estrone Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical…
- Recall number
- D-0657-2017
- FDA classification
- Class II
- Brand / firm
- Qinhuangdao Zizhu Pharmaceutical, Co.
- Sold / distributed
- Product distributed to NY, TX, SC, CO, MN and NJ
Why it was recalled
cGMP Deviations; lack of quality assurance.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
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)
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