Announcement on the Progress of Recall of the Company's Products "Compound Pseudostellaria Granules"


Time:

2016-01-08

Announcement on the Progress of Recall of the Company's Products

is based on our company's product "Compound Pseudostellaria Granules" (approval number: Chinese Medicine Zhunzi B20020899;) The suppliers of bulk drugs include "Chongqing Quanxin Xiangsheng Biopharmaceutical Co., Ltd." mentioned in CFDA's Document No. 111 of 2015 issued on December 30, 2015 and Food and Drug Administration's Document No. 275. In order to ensure patients' medication safety and control risks to the greatest extent, before finally getting the safety risk assessment conclusion of our company's product compound Pseudostellaria particles, our company took the initiative to start the three-level recall procedure on December 30, 2015, and carried out a comprehensive risk assessment at the same time.

At present, the company has notified relevant business and user units to stop selling, use and recall all batches of compound Pseudostellaria heterophylla granules, and recall them according to procedures. The company's stock of compound Pseudostellaria heterophylla granules has been suspended and sealed up. See Schedule 1 for the list of sales units.
The inventory quantity of each unit is in the process of further verification, statistics and summary.
In order to ensure that there is no omission, the follow-up will continue to carry out in-depth verification of sales flow.
Attached: product sales flow table
Fujian Mindong Lijiexun Pharmaceutical Co., Ltd.
January 8, 2016