China NMPA Product Recall - Uterine warming patch

Jinan Hanci Biotechnology Co., Ltd. initiated a voluntary Class III recall of its Warming Uterus Patches (Registration Certificate No.: Lu Xie Zhu Zhun 20182260067), as announced by the National Medical Products Administration (NMPA) on December 20, 2019. This action followed a re-inspection of retained product samples, which revealed a significant issue: one sample's maximum temperature reached 67.2℃, surpassing the technical requirement of 65℃. This deviation was identified as potentially causing mild discomfort to users.

Operating under the regulatory guidance of the NMPA, the company implemented a series of corrective measures. Jinan Hanci Biotechnology Co., Ltd. proactively identified and informed all retailers that had received the affected batch (batch number 20190206, totaling 5760 boxes) through direct communication. Retailers were instructed to assist in the comprehensive return of all units from this specific lot. The recall effort extends across several regions, including Xinjiang, Ningxia, Yunnan, Sichuan, Guizhou, Jiangxi, Anhui, Hunan, and Shaanxi Provinces. The company further committed to conducting in-depth sampling and testing of the recalled products to pinpoint the underlying cause of the temperature discrepancy, with all recovered products designated for destruction.