FDA (Drugs) recall action 76890
The FDA (Drugs) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.
cGMP Deviations; lack of quality assurance.
The agency’s own wording, quoted from the enforcement report.
The FDA is recalling bulk Estradiol Non-Micronized, USP, manufactured by Qinhuangdao Zizhu Pharmaceutical, Co. due to cGMP deviations and lack of quality assurance.
Qinhuangdao Zizhu Pharmaceutical is recalling Estradiol Micronized Bulk for prescription compounding due to cGMP deviations and lack of quality assurance.
The FDA is recalling bulk Ethinyl Estradiol Micronized manufactured by Qinhuangdao Zizhu Pharmaceutical due to cGMP deviations and lack of quality assurance.
The FDA is recalling bulk levonorgestrel manufactured by Qinhuangdao Zizhu Pharmaceutical due to cGMP deviations and lack of quality assurance.
Qinhuangdao Zizhu Pharmaceutical is recalling Testosterone Micronized Bulk due to cGMP deviations and lack of quality assurance. The product was distributed to six states.
Qinhuangdao Zizhu Pharmaceutical is recalling bulk Estriol Micronized, USP, due to cGMP deviations and lack of quality assurance. The product is distributed to pharmacies in six states for prescription compounding.
The FDA is recalling Estrone Micronized bulk drug products manufactured by Qinhuangdao Zizhu Pharmaceutical due to cGMP deviations and lack of quality assurance.