# FDA recall D-0654-2017

> **Qinhuangdao Zizhu Pharmaceutical, Co.** · Class II · drug recall initiated 2017-03-24.

## 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 for recall

cGMP Deviations; lack of quality assurance.

## Distribution

Product distributed to NY, TX, SC, CO, MN and NJ

## Key facts

- **Recall number:** D-0654-2017
- **Recalling firm:** Qinhuangdao Zizhu Pharmaceutical, Co.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-03-24
- **Report date:** 2017-04-19
- **Termination date:** 2018-07-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Qinhuangdao, N/A, China

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0654-2017

## Citation

> AI Analytics. FDA recall D-0654-2017. Retrieved 2026-05-23 from https://api.ai-analytics.org/recall/D-0654-2017. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*