Why it was recalled
cGMP Deviations; lack of quality assurance.
Product description
Estriol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China 44132-007-06
Lot numbers, UPCs & expiration codes
Batch 81801504002 to 81801701003, exp 4/12/2017 through 1/19/2019
Where it was sold
Product distributed to NY, TX, SC, CO, MN and NJ
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0656-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 24, 2017
- FDA report date
- Apr 19, 2017
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Qinhuangdao Zizhu Pharmaceutical, Co.
Original FDA data
Every field from FDA enforcement report D-0656-2017, exactly as published.
Show all FDA fields
- City
- Qinhuangdao
- Status
- Terminated
- Country
- China
- Event ID
- 76890
- Address
- No 10, Longhai Road
- Address (line 2)
- Economic & Technological Development Zon
- Code information
- Batch 81801504002 to 81801701003, exp 4/12/2017 through 1/19/2019
- Report date
- Apr 19, 2017
- Product type
- Drugs
- Recall number
- D-0656-2017
- Classification
- Class II
- Recalling firm
- Qinhuangdao Zizhu Pharmaceutical, Co.
- Termination date
- Jul 3, 2018
- Reason for recall
- cGMP Deviations; lack of quality assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Estriol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China 44132-007-06
- Distribution pattern
- Product distributed to NY, TX, SC, CO, MN and NJ
- Recall initiation date
- Mar 24, 2017
- Initial firm notification
- Letter
- Center classification date
- Apr 11, 2017