RecallRadar

FDA Drug recall D-0655-2017

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

On 2017-04-19 the FDA classified a Class II recall of Estradiol Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinh… by Qinhuangdao Zizhu Pharmaceutical, citing cGMP Deviations; lack of quality assurance.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0655-2017
ClassificationClass II
Statusterminated
Initiated2017-03-24
Published2017-04-19
Last updated2026-09-13 11:51 UTC
CompanyQinhuangdao Zizhu Pharmaceutical
DistributionCO, MN, NJ, NY, SC, TX

Product

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

Reason

cGMP Deviations; lack of quality assurance.

Identifiers

code_infoBatch 80701510001 to Batch 80001607002, exp 10/22/2017 through 7/5/2018

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0655-2017%22

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