# China NMPA Drug Inspection - Shaanxi Xiyue Pharmaceutical Co., Ltd. - Chlorpheniramine maleate tablets

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shaanxi-xiyue-pharmaceutical-co-ltd/e0745eee-35a2-4aca-aa0f-4943b0d6200c/
Source feed: China

> China NMPA drug inspection for Shaanxi Xiyue Pharmaceutical Co., Ltd. published November 23, 2018. Drug: Chlorpheniramine maleate tablets. On November 23, 2018, the Henan Provincial Food and Drug Administration announced the findings of drug inspections that 

---

## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement from the Henan Provincial Food and Drug Administration regarding 6 batches of substandard drugs (Issue No. 14, 2018)
- Company Name: Shaanxi Xiyue Pharmaceutical Co., Ltd.
- Publication Date: 2018-11-23
- Drug Name: Chlorpheniramine maleate tablets
- Inspection Finding: Properties do not meet regulations
- Action Taken: The Henan Provincial Food and Drug Administration has instructed relevant food and drug regulatory departments to take necessary risk control measures such as sealing, seizing, and suspending sales of substandard drugs, and to investigate and punish the units that sourced the samples in accordance with the law.
- Summary: On November 23, 2018, the Henan Provincial Food and Drug Administration announced the findings of drug inspections that revealed six batches of drugs from six different companies were substandard. Inspections conducted by various provincial and municipal drug institutes identified critical quality control issues. Violations included substandard appearance and microscopic characteristics for "Fried Yam" from Henan Qingshan Pharmaceutical Co., Ltd., and "Dictamnus dasycarpus" from Nanyang Fanglin Traditional Chinese Medicine Pieces Co., Ltd. Shanxi Yunpeng Pharmaceutical Co., Ltd.'s "Diclofenac Sodium Tablets" also failed due to appearance. Kaifeng Pharmaceutical (Group) Co., Ltd.'s "Gentamicin Sulfate Injection" and Henan Lixin Pharmaceutical Co., Ltd.'s "Ribavirin Injection" were found to contain visible foreign matter, while "Cornus officinalis" from Henan Tongzhentang Traditional Chinese Medicine Pieces Co., Ltd. contained impurities. These deficiencies were evaluated against the Chinese Pharmacopoeia 2015 Edition and other relevant national standards. The Henan Provincial Food and Drug Administration has instructed regulatory departments to implement immediate risk control measures, including sealing, seizing, and suspending the sale of the affected drugs. Furthermore, investigations will be conducted, and legal actions will be taken against the implicated manufacturers and sourcing units to uphold drug safety regulations.

Company: https://www.globalkeysolutions.net/companies/shaanxi-xiyue-pharmaceutical-co-ltd/2c2dfb62-b98f-4189-b05b-42c224bf136b/