Survey of paracetamol detected in "Yinqiao Jiedu tablet" sold to Hong Kong

Source: CFDA 2016-4-22 recently, the food and drug administration received a report from the Hong Kong Department of health, which found that the "Yinqiao detoxification tablet" (batch No.: mh-151) produced by Tianjin Zhongxin Pharmaceutical Group Co., Ltd longshunrong pharmaceutical factory (hereinafter referred to as longshunrong pharmaceutical factory) contained trace paracetamol (the detection amount is 0.083mg/tablet), "Yinqiao Jiedu tablet" approved prescription does not contain paracetamol, should not be detected The State Food and drug administration immediately ordered the Tianjin municipal market and quality supervision and Administration Commission to conduct comprehensive supervision and inspection on the production enterprises involved in the products The relevant information is hereby notified as follows: the involved Yinqiao antidote tablet is a drug registered in Hong Kong by longshunrong pharmaceutical factory, and the registration certificate number is marked as hkp-00056 The involved products were produced in June 2014, with a total of 46 cases, sold to 31 cases in Hong Kong and 15 cases in stock, and the validity period is until June 16, 2018 Hong Kong Minghua company is its distribution agent The products involved are not sold in mainland China The approval number of Yinqiao Jiedu Tablets sold by longshunrong pharmaceutical factory in mainland China is marked as gyzz12020274, and they are not produced in one production line with the related products sold in Hong Kong According to the investigation, Yinqiao antidote tablet produced by longshunrong pharmaceutical factory and refined Yinqiao antidote tablet share the same tablet press The approved prescription of refined Yinqiao antidote tablet contains paracetamol 60mg / tablet, resulting in cross contamination of the product due to incomplete clearance In November 2014, the enterprise found that the Yinqiao Jiedu tablet with the batch number of mh-151 contained trace paracetamol On December 11, 2014, longshunrong pharmaceutical factory informed Hong Kong Minghua company to stop selling the batch of products, seal them in place and destroy them Longshunrong pharmaceutical factory has destroyed 15 boxes of this batch of products in stock According to Minghua Hong Kong, April 20, 2016 According to a letter sent to Tianjin Zhongxin Pharmaceutical Group Co., Ltd., Minghua company sent samples of the remaining products to Hong Kong Standards and Testing Center Co., Ltd for inspection after destroying some of the involved products Because paracetamol was not detected, Hong Kong Minghua company sold the involved batch of products again without informing longshunrong pharmaceutical factory, which led to this incident In the process of pharmaceutical production, the cross contamination of drugs caused by incomplete clearance is a serious quality event in violation of GMP, which reflects the serious defects in the quality management of the enterprise The General Administration of food and drug administration requires Tianjin municipal market and quality supervision and Administration Commission to order longshunrong pharmaceutical factory to stop production for rectification, recall the involved products completely, and file a case for investigation of its illegal production behaviors such as drug GMP violation; expand the sampling batch of relevant products of the enterprise, and timely release the relevant information to the society The food and drug administration has notified the Hong Kong Department of health of the unauthorized sale of recalled products by Minghua Tip: paracetamol, also known as paracetamol, is a kind of antipyretic and analgesic drug, which is applicable to relieve mild to moderate pain, such as fever, headache, joint pain, neuralgia caused by cold, etc The common oral dose for adults is 300mg - 600mg, and the daily dose should not exceed 2000mg Some common cold medicines contain paracetamol, which is about 120-500mg.