FDA recall D-0657-2017

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.

Distribution

Product distributed to NY, TX, SC, CO, MN and NJ

Key facts

Status

Terminated

Initiation date

2017-03-24

Report date

2017-04-19

Termination date

2018-07-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Qinhuangdao, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0657-2017