China NMPA Drug Inspection - Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd. - Cefepime Hydrochloride for Injection

The Chongqing Municipal Food and Drug Administration released its second Drug Quality Announcement for 2018 on May 11, 2018. This announcement detailed the outcomes of drug sampling inspections conducted throughout the city, aimed at enhancing drug quality oversight, regulating market order, and ensuring public drug safety. The inspections identified seven batches of drugs from various manufacturers that did not meet quality standards. Shanxi Lanhua Pharmaceutical Co., Ltd. and Shanxi Tongda Pharmaceutical Co., Ltd. were cited for Aspirin Enteric-coated Tablets containing non-compliant levels of free salicylic acid. Harbin Pharmaceutical Group General Factory's Norfloxacin Capsules failed dissolution tests, while Shandong Beida Gaoke Huatai Pharmaceutical Co., Ltd.'s Hydrobromide for Injection and Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd.'s Cefepime Hydrochloride for Injection were non-compliant regarding solution clarity. Additionally, Sichuan Shengle Pharmaceutical Co., Ltd.'s Mistletoe and Sichuan Haobo Pharmaceutical Co., Ltd.'s Typha orientalis exhibited appearance defects. Notably, the Mistletoe product was found to be purchased through illegal channels, and the Typha orientalis was compromised by insect infestation due to improper storage. The regulatory benchmarks for these evaluations included the Chinese Pharmacopoeia (2010 and 2015 editions) and national drug standards. This public disclosure highlights the necessity for manufacturers and distributors to rectify identified quality issues and strictly adhere to pharmaceutical regulations to safeguard consumer health.