# China NMPA Drug Inspection - Jilin Shuangyao Pharmaceutical Group Co., Ltd. - Artificial bezoar metronidazole capsules

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/jilin-shuangyao-pharmaceutical-group-co-ltd/e339ebf6-6ab5-482e-a34b-3540f8ea3800/
Source feed: China

> China NMPA drug inspection for Jilin Shuangyao Pharmaceutical Group Co., Ltd. published November 17, 2017. Drug: Artificial bezoar metronidazole capsules. On November 17, 2017, China's State Administration for Market Regulation (formerly State Food and Drug Administration) a

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: State Administration for Market Regulation Announcement No. 186 of 2017 Regarding 39 Batches of Substandard Drugs
- Company Name: Jilin Shuangyao Pharmaceutical Group Co., Ltd.
- Publication Date: 2017-11-17
- Drug Name: Artificial bezoar metronidazole capsules
- Inspection Finding: [Content Determination] (bilirubin)
- Action Taken: Relevant provincial food and drug administration departments have taken control measures such as sealing and seizing, required enterprises to suspend sales and use, recall products, and carry out rectification. Additionally, provincial departments are required to initiate investigations into illegal acts of producing and selling unqualified drugs, and publicly announce the handling results for relevant enterprises or units within three months.
- Summary: On November 17, 2017, China's State Administration for Market Regulation (formerly State Food and Drug Administration) announced findings from drug testing institutions, identifying 39 batches of substandard drugs from eight pharmaceutical companies. Key manufacturers included Guangxi Chunzhengtang Pharmaceutical Co., Ltd., Guangxi Jinye Pharmaceutical Co., Ltd., Jiangsu Puhua Kesheng Pharmaceutical Co., Ltd., Jilin Shuangyao Pharmaceutical Group Co., Ltd., Gansu Minhai Pharmaceutical Co., Ltd., Guangxi Shengte Pharmaceutical Co., Ltd., and Youhua Pharmaceutical (Leshan) Co., Ltd.
The primary violations involved various quality control failures. Guangxi Chunzhengtang and Youhua Pharmaceutical experienced solubility issues with Guaifenesin Pentotropin Promethazine Granules. Guangxi Jinye's Dextromethorphan tablets and Guangxi Shengte's Anti-inflammatory and Antipyretic Granules failed content determination. Jiangsu Puhua Kesheng's Ribavirin eye drops had quantity discrepancies, Jilin Shuangyao's Artificial Bezoar Metronidazole Capsules showed content determination issues, and Gansu Minhai's Anti-inflammatory and Antipyretic Granules exceeded microbial limits.
Operating under the *Drug Administration Law of the People's Republic of China* and national drug standards, including the Pharmacopoeia, regulatory authorities initiated immediate actions. These included sealing and seizing affected products, suspending sales and usage, and ordering recalls. Provincial food and drug administrations were mandated to thoroughly investigate these violations, publicly release their findings within three months, and report promptly to the State Food and Drug Administration, ensuring accountability and corrective measures.

Company: https://www.globalkeysolutions.net/companies/jilin-shuangyao-pharmaceutical-group-co-ltd/727c4706-a90a-4402-9ed2-41256c4602ac/