D-0654-2017 Class II Terminated
FDA drug recall D-0654-2017 was initiated by Qinhuangdao Zizhu Pharmaceutical, Co. on March 24, 2017 and is designated Class II. Reason for recall: cGMP Deviations; lack of quality assurance. The recall status is terminated (terminated July 3, 2018). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- April 19, 2017
- Initiation Date
- March 24, 2017
- Termination Date
- July 3, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Estradiol Micronized Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China (NDC 44132-001-01) (44132-001-06)
Reason for Recall
cGMP Deviations; lack of quality assurance.
Distribution Pattern
Product distributed to NY, TX, SC, CO, MN and NJ
Code Information
Batch 80001512002 to Batch 80801604003, exp 10/22/2017 through 3/30/3018