China NMPA Product Recall - Ferric ammonium citrate

The National Medical Products Administration (NMPA) issued an announcement on December 30, 2015, regarding significant quality issues with ferric ammonium citrate produced by Chongqing Quanxin Xiangcheng Biopharmaceutical Co., Ltd. An on-site inspection revealed that the company failed to adequately control the quality of the iron raw material used in its production. Investigations confirmed high chromium content, ranging from 643-1178 mg/kg, in the finished ferric ammonium citrate product and its raw materials. High chromium levels (149-342 mg/kg) were also detected in iron filings from the steel bars used in the manufacturing process, indicating a clear contamination risk.

This compromised raw material was supplied to 40 pharmaceutical manufacturers across the country. Consequently, the NMPA mandated immediate actions. Chongqing Quanxin Xiangcheng Biopharmaceutical Co., Ltd. was ordered to have its GMP certificate for ferric ammonium citrate revoked by the Chongqing Municipal Food and Drug Administration, pending further investigation. The 40 affected pharmaceutical companies were directed to immediately cease using the problematic ferric ammonium citrate, conduct a comprehensive investigation into the drugs produced with it, recall all impacted products from the market, and publicly report this information by January 4, 2016. Provincial Food and Drug Administrations were instructed to oversee these recall efforts to safeguard public health.