China NMPA Product Recall - Far-infrared anti-inflammatory and analgesic patch

The National Medical Products Administration (NMPA) issued a public notice on September 9, 2021, concerning a voluntary Class III recall initiated by Anhui Ruikang Pharmaceutical Co., Ltd. This regulatory action specifically involves their far-infrared anti-inflammatory and analgesic patches, with particular attention to batch number 20200508. The decision to recall was prompted by the product's failure during a routine random quality inspection. While the document does not elaborate on the specific nature of the defect, the failure indicates non-compliance with established quality or safety standards. The recall details were disseminated via the Anhui Provincial Drug Administration website, underscoring the layered oversight within the Chinese medical device regulatory system. As a required action, Anhui Ruikang Pharmaceutical Co., Ltd. is mandated to execute this Class III recall, which typically applies when exposure to the product is not likely to cause serious adverse health consequences. The company is expected to furnish comprehensive information in a "Medical Device Recall Form," detailing the affected models, specifications, and batches to ensure the complete removal of non-compliant products from the market and to safeguard public health in accordance with NMPA regulations.