FDA Drug Moderate Class II Terminated

Estradiol Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China

Reported: April 19, 2017 Initiated: March 24, 2017 #D-0655-2017

Product Description

Reason for Recall

cGMP Deviations; lack of quality assurance.

Details

Recalling Firm: Qinhuangdao Zizhu Pharmaceutical, Co.
Units Affected: N/A
Distribution: Product distributed to NY, TX, SC, CO, MN and NJ
Location: Qinhuangdao, N/A

Frequently Asked Questions

What product was recalled? ▼

Estradiol Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China. Recalled by Qinhuangdao Zizhu Pharmaceutical, Co.. Units affected: N/A.

Why was this product recalled? ▼

cGMP Deviations; lack of quality assurance.

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on April 19, 2017. Severity: Moderate. Recall number: D-0655-2017.