Drug product
Estradiol Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China
D-0655-2017
Product summary
- Event
- Event 76890
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0655-2017
Official wording
Reason: cGMP Deviations; lack of quality assurance.
Code information: Batch 80701510001 to Batch 80001607002, exp 10/22/2017 through 7/5/2018
Distribution pattern: Product distributed to NY, TX, SC, CO, MN and NJ
Derived failure modes
-
Manufacturing or process control
cGMP Deviations