China NMPA Product Recall - Bupleurum

The National Medical Products Administration (NMPA) issued a formal notice concerning a product recall by Xinjiang Bencao Tang Pharmaceutical Co., Ltd. This action followed an inspection on January 23, 2017, conducted by the Xinjiang Uygur Autonomous Region Food and Drug Inspection Institute. The inspection revealed that a specific batch of the company's traditional Chinese medicine decoction pieces, "Bupleurum" (batch number 16070817, 1 kg/bag), failed to meet required quality standards. In response to this non-compliance, the NMPA, referencing Article 26 of its "Regulations on Drug Recall Management" (Order No. 29), mandated Xinjiang Bencao Tang Pharmaceutical Co., Ltd. to immediately recall all affected units of the "Bupleurum" product. The company was further instructed to submit a comprehensive written report detailing the recall process and its completion to the Xinjiang Uygur Autonomous Region Food and Drug Administration by March 1, 2017. This regulatory directive underscores the NMPA's commitment to upholding pharmaceutical quality and ensuring consumer safety through stringent enforcement and prompt corrective measures.