# China NMPA Drug Inspection - Baotou Traditional Chinese Medicine Co., Ltd. - Niuhuang Jiedu Pills

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/baotou-traditional-chinese-medicine-co-ltd/e1ee6965-6c19-4882-a569-6b4f68b75b4a/
Source feed: China

> China NMPA drug inspection for Baotou Traditional Chinese Medicine Co., Ltd. published January 14, 2020. Drug: Niuhuang Jiedu Pills. The Inner Mongolia Autonomous Region Drug Administration, operating under the broader regulatory framework of the Nation

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement from the Drug Administration of Inner Mongolia Autonomous Region Regarding Two Batches of Drugs That Failed to Meet Regulations
- Company Name: Baotou Traditional Chinese Medicine Co., Ltd.
- Publication Date: 2020-01-14
- Drug Name: Niuhuang Jiedu Pills
- Inspection Finding: Content determination did not meet the requirements
- Action Taken: Production, sales, and use have been suspended; products have been actively recalled; rectification measures have been implemented; and an investigation is underway.
- Summary: The Inner Mongolia Autonomous Region Drug Administration, operating under the broader regulatory framework of the National Medical Products Administration (NMPA), issued an important announcement on January 7, 2020. This document concerns the identification of substandard drugs within its jurisdiction. Specifically, the administration reported that two batches of drugs were found to be non-compliant with established quality standards. The key issues detailed in the accompanying information include unacceptable levels of sulfur dioxide residue, a common concern in Chinese medicinal materials, where excessive amounts pose potential health risks. Additionally, non-compliance was noted in content determination, indicating that the quantity of active ingredients in the drugs did not meet national specifications. This deficiency is critical as it directly impacts the drug's intended quality and therapeutic efficacy. In response to these findings, the inspection department has been strictly instructed to launch a comprehensive investigation into the relevant units responsible for these substandard products. The regulatory body mandates that this investigation be completed, and its findings, including the resolution of the issues, must be publicly disclosed within three months from the date the inspection report was received, underscoring a commitment to public health and drug safety.

Company: https://www.globalkeysolutions.net/companies/baotou-traditional-chinese-medicine-co-ltd/a7a539d4-e4e9-4c8e-9563-3a803cf96f2e/