China NMPA Drug Inspection - Xinxiang Pharmaceutical Co. Ltd. - Clotrimazole Cream

This National Drug Quality Bulletin, issued by the State Food and Drug Administration (now NMPA) on May 10, 2010, presents the outcomes of a nationwide sampling inspection to enhance drug supervision and safeguard public health. Operating under the national drug sampling inspection work plan, the regulatory body evaluated 23 varieties of drugs. While the majority of the 3098 sampled batches met standards, 7 batches (representing 9 products) were identified as non-compliant.

Key issues and manufacturers involved include Heilongjiang Wusulijiang Pharmaceutical Co., Ltd., which had two batches of *Acanthopanax senticosus* Injection fail for content determination. Xi'an Qinba Pharmaceutical Co., Ltd.'s *Curcuma zedoaria* oil preparation had one batch non-compliant for content determination. Fujian Sanai Pharmaceutical Co., Ltd.'s *Houttuynia cordata* injection showed an incorrect pH value in one batch. Additionally, Xinxiang Huaqing Pharmaceutical Co., Ltd. had two batches of Clotrimazole Cream fail content determination, while Wuhu Sanyi Pharmaceutical Co., Ltd.'s Clotrimazole Cream batches failed for both bacterial count and content determination.

These findings, despite overall good product quality, necessitate that the implicated companies undertake immediate corrective and preventative actions to resolve the identified quality deficiencies and ensure full adherence to drug quality standards.