China NMPA Drug Inspection - Wuhu Kangqi Pharmaceutical Co., Ltd. - Vitamin K1 injection

The Hubei Province Drug Quality Announcement, issued on July 27, 2017, reported the findings from drug quality inspections conducted across the province during the second quarter of 2017. These inspections involved drug production, operation, and use units, revealing 30 batches of drugs that did not meet established quality standards. Key violations included quality control deficiencies such as improper dissolution (e.g., Norfloxacin Capsules from Chengdu Jinhua Pharmaceutical Co., Ltd.), excessive related substances (e.g., Vitamin K1 Injection from Wuhu Kangqi Pharmaceutical Co., Ltd. and Shandong Yikang Pharmaceutical Co., Ltd.), and issues with pH value, weight variation, moisture content, or product identification. Notably, counterfeit drugs like Osteoarthritis Capsules and Compound Cough and Asthma Relief Capsules were found to contain undeclared active ingredients, specifically Prednisolone Acetate. Several traditional Chinese medicine preparations and raw materials also exhibited non-compliance in their properties or purity. For some non-compliant batches, manufacturers, including Qingdao Huanghai Pharmaceutical Co., Ltd., disputed production. Operating under the