Explanation of Shouyuan Chemical Industry Co., Ltd. to recover “50 mg of zisha flat film ingot”

In response to recent international discoveries that some of the raw materials for sartan drugs contain animal carcinogenic components such as NDEA or NDMA, the Food and Drug Administration of the Ministry of Health and Welfare (hereinafter referred to as the Food and Drug Administration) has adopted a series of enhanced control measures, including strengthening active sampling and announcing inspection methods. , requiring the operator to self-inspect. The Food and Drug Administration received a notice from Shouyuan Chemical Industry Co., Ltd. on December 26, 2007, and found that the No. NDEA ingredient was detected in the batch of Losartan API of the IPCA raw material drug factory in India. It was used in the "Vasella Flat Film Ingot 50". "Mg" drugs (11 batches in total), and started the recycling operation immediately on December 27, 107. On the same day, the Food and Drug Administration immediately notified the medical institutions and the pharmacy to immediately stop the supply and resume the collection within one month (before January 27, 108). The Health Bureau was requested to supervise the removal of the removal. Medical institutions and pharmacies have been notified via VPN. Another reminder is that patients who are using the drug are mainly used for diseases such as high blood pressure that require regular medication control. Therefore, it is not recommended to stop the drug at any time. When returning to the clinic as soon as possible, discuss with the doctor and prescribe other appropriate drugs.

Source: Ministry of Health and Welfare