FDAFDA · Food and drugs·Recall number D-0655-2017
Estradiol Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China
Published April 19, 2017 · Recall initiated: March 24, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP Deviations; lack of quality assurance.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Qinhuangdao Zizhu Pharmaceutical, Co.
- Distributor
- Product distributed to NY, TX, SC, CO, MN and NJ
- Lot
- Batch 80701510001 to Batch 80001607002, exp 10/22/2017 through 7/5/2018
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- China
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