China NMPA Product Recall - Natural latex rubber condoms

Jining Weikang Adhesive Industry Co., Ltd. initiated a voluntary Class III recall for its natural latex rubber condoms, specifically batch number 20180103. This recall, publicly announced on December 20, 2019, stemmed from findings during a national random inspection by the Inner Mongolia Autonomous Region Drug Inspection Institute. The primary issue identified was that condoms from the affected batch, produced in January 2018, contained pinholes that did not meet the required medical device registration standards.Operating under the regulatory framework of the National Medical Products Administration (NMPA), the company promptly recalled the non-conforming products. Required actions included notifying the local drug administration department, which then supervised the disposal of the recalled items. The local food and drug administration also seized the affected products. As part of corrective measures, Jining Weikang Adhesive Industry Co., Ltd. committed to implementing stricter production quality control, enhancing staff knowledge of quality inspection requirements, and refining handling methods to prevent similar issues in the future, underscoring their commitment to product safety and regulatory compliance.