China NMPA Product Recall - Ferric ammonium citrate

On December 30, 2015, the National Medical Products Administration (NMPA) issued a notice in response to significant risks identified with Ferrous Ammonium Citrate products from Chongqing Quanxin Xiangcheng Biopharmaceutical Co., Ltd. This regulatory action was based on the NMPA's "Announcement on the Risk of Ferrous Ammonium Citrate Products" (No. 111 of 2015).

The NMPA mandated several critical actions: The Chongqing Municipal Food and Drug Administration was directed to immediately revoke the Good Manufacturing Practice (GMP) certificate for Ferrous Ammonium Citrate held by Chongqing Quanxin Xiangcheng. The company was ordered to investigate its production and sales thoroughly, recall all in-date affected products, and face an official investigation. Chongqing Quanxin Xiangcheng also had to publicly disclose its sales channels and recall information by December 31, 2015.

Across China, provincial food and drug administrations were instructed to ensure pharmaceutical manufacturers cease using the problematic raw material, identify affected drug batches, clarify sales channels, and recall their in-date products from the market, with public announcements due by January 4, 2016. Additionally, drug distribution and use units nationwide were ordered to stop selling and using relevant drugs from the 40 enterprises implicated in the initial risk announcement and cooperate with the recall efforts. These measures highlight a robust regulatory response to safeguard public health.