Recalls / Class II
Class IID-0655-2017
Product
Estradiol Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China
- Affected lot / code info
- Batch 80701510001 to Batch 80001607002, exp 10/22/2017 through 7/5/2018
Why it was recalled
cGMP Deviations; lack of quality assurance.
Recalling firm
- Firm
- Qinhuangdao Zizhu Pharmaceutical, Co.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- No 10, Longhai Road, Economic & Technological Development Zon, Qinhuangdao, N/A N/A, China
Distribution
- Quantity
- N/A
- Distribution pattern
- Product distributed to NY, TX, SC, CO, MN and NJ
Timeline
- Recall initiated
- 2017-03-24
- FDA classified
- 2017-04-11
- Posted by FDA
- 2017-04-19
- Terminated
- 2018-07-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0655-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.