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)

Recall Number: D-0657-2017

Firm: Qinhuangdao Zizhu Pharmaceutical, Co.

Classification: Class II

Status: Terminated

Report Date: 20170419

Initiation Date: 20170324

Termination Date: 20180703

cGMP Deviations; lack of quality assurance.

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)