FDA Drug recall D-0654-2017
Estradiol Micronized Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 06…
- FDA Drug
- Class II
- terminated
- Published 2017-04-19
On 2017-04-19 the FDA classified a Class II recall of Estradiol Micronized Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 06… by Qinhuangdao Zizhu Pharmaceutical, citing cGMP Deviations; lack of quality assurance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0654-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-24 |
| Published | 2017-04-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Qinhuangdao Zizhu Pharmaceutical |
| Distribution | CO, MN, NJ, NY, SC, TX |
Product
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
cGMP Deviations; lack of quality assurance.
Identifiers
| code_info | Batch 80001512002 to Batch 80801604003, exp 10/22/2017 through 3/30/3018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0654-2017%22
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