China NMPA Drug Inspection - Hubei Likang Medical Materials Co., Ltd. - Halogenated butyl rubber stoppers for sterile powders for injection, batch number 1605027

On April 27, 2017, China's State Food and Drug Administration (SFDA) issued an announcement (No. 66 of 2017) regarding substandard drug packaging materials. The announcement followed tests by national and provincial institutes, which identified issues with six batches of products from five different companies. The affected companies include Linyi Yulong Medical Materials Co., Ltd., Guangdong Jixin Plastic Products Co., Ltd., Shantou Wan'an Plastic Crafts Co., Ltd., Shenyang Wanquan Rubber Products Factory, and Hubei Likang Medical Materials Co., Ltd. The substandard products were identified as oral solid pharmaceutical polypropylene bottles and halogenated butyl rubber stoppers for injectable sterile powders, with specific batch numbers produced in 2016. The primary violations concerned failures in the leachate test and identification. In response to these findings, provincial food and drug administrations initiated immediate control measures, including sealing and seizing the affected products. The implicated companies were mandated to cease sales and use, recall the substandard batches, and implement corrective actions. Operating under the *Drug Administration Law of the People's Republic of China*, the SFDA further directed provincial administrations to investigate the companies for illegal activities. These authorities are required to publicize their enforcement outcomes within three months and report back to the SFDA. This action underscores a commitment to maintaining pharmaceutical quality and patient safety.