China NMPA Drug Inspection - Tianjin Second Hospital - Compound Menthol Nasal Drops

The Tianjin Municipal Market and Quality Supervision and Management Commission announced on January 15, 2018, the results of its 2017 drug supervision and sampling inspections, revealing nine batches of drugs that failed to meet quality standards. These inspections were conducted to ensure the safety and efficacy of drugs across production, operation, and usage within Tianjin.

Key manufacturers and institutions cited for deficiencies include Anhui Huilong Traditional Chinese Medicine Pieces Co., Ltd., whose Cassia Seed failed content determination, and Anguo Qiao Traditional Chinese Medicine Pieces Co., Ltd., with Beehives showing unqualified total ash and acid-insoluble ash. Bozhou Boyaotang Pharmaceutical Co., Ltd.'s Cistanche deserticola did not meet moisture and total ash specifications, and Hebei Shunquanlong Pharmaceutical Co., Ltd.'s Gastrodia elata was found to have an unqualified appearance.

Furthermore, medical institution preparations also showed issues. Tianjin Second Hospital's Compound Menthol Nasal Drops had identification problems related to camphor, and two batches of its Ciprofloxacin Hydrochloride Lotion failed appearance standards. Tianjin Medical University General Hospital's Compound Menthol Nasal Drops exhibited unqualified content, and its Anti-leukoplakia Cream exceeded microbial limits.

These violations were assessed against the Chinese Pharmacopoeia (2010 and 2015 editions) and the "Tianjin Medical Institution Preparation Standards" (2016 Edition). Regulatory departments have initiated investigations and necessary actions to address these quality concerns, thereby ensuring public health and drug safety.