China NMPA Product Recall - Ferric ammonium citrate

The National Medical Products Administration (NMPA) issued a notice regarding a product recall due to significant quality control failures at Chongqing Quanxin Xiangsheng Biopharmaceutical Co., Ltd. Publicized around December 2015, this regulatory action stemmed from national drug sampling inspections that detected high chromium content in various pharmaceutical formulations. Subsequent investigation by the State Administration for Market Regulation (SAMR) traced the contamination to ferric ammonium citrate supplied by Chongqing Quanxin Xiangsheng Biopharmaceutical Co., Ltd.

Preliminary findings revealed that the company failed to adequately control the quality of its raw material iron, specifically iron filings from No. 45 steel bars. This resulted in elevated chromium levels (643-1178 mg/kg) in its ferric ammonium citrate product, which was distributed to 40 other pharmaceutical manufacturers.

In response, the SAMR mandated that these 40 manufacturers immediately cease using the affected ferric ammonium citrate, investigate its use in their products, identify all affected batches within their shelf life, and promptly recall them. Furthermore, the Chongqing Food and Drug Administration was instructed to revoke Chongqing Quanxin Xiangsheng Biopharmaceutical Co., Ltd.'s Good Manufacturing Practice (GMP) certificate, supervise a comprehensive recall of all affected products, and initiate a formal investigation into the company. Provincial food and drug administrations were also tasked with overseeing regional recall efforts and ensuring distributors and users ceased handling the implicated products. Public disclosure of sales and recall information was required by December 31, 2015, and January 4, 2016, for different parties.