Notice of Epizyme, Inc. voluntary product recall for Tazemetostat Hydrobromide Tablets (Tazverik®)
Epizyme, Inc. as the marketing authorization holder of Tazemetostat Hydrobromide Tablets (Tazverik®) (the “Product”), reports that due to the emergence of an unfavorable benefit/risk profile and in order to protect patient safety, Epizyme Inc. has decided to perform a voluntary recall for all batches of the Product Tazemetostat Hydrobromide Tablets, manufactured by Patheon Pharmaceuticals Inc. , 2110 East Galbraith Road, Cincinnati, OH 45237, USA, from the Chinese market, in accordance with the Measures for the Administration of Drug Recall and other relevant regulations.
The Product distributed in China is 200 mg tablets, with the batch number: 3237911S. This is classified as a Class I drug recall.
Epizyme in collaboration with its domestic agent/ licensee HUTCHMED Limited has initiated the immediate withdrawal and product recall of the Product from the Chinese market.
Epizyme, Inc.对氢溴酸他泽司他片（达唯珂®）主动召回的通知
Epizyme, Inc.作为氢溴酸他泽司他片（达唯珂®）（以下简称“本品”）的药品上市许可持有人 报告，由于本品出现潜在不利的获益-风险特征，为了保护患者安全，根据《药品召回管理办法》等相关规定，Epizyme, Inc. 决定从中国市场主动召回由 Patheon Pharmaceuticals Inc. （地址：2110 East Galbraith Road, Cincinnati, OH 45237, USA ）公司生产的本品所有批次。涉及到在中国销售的本品规格为200mg，批次为3237911S 。召回级别为I级召回。
Epizyme, Inc.与其境内代理人/被授权人和记黄埔医药（上海）有限公司合作，已启动从中国市场立即撤市及召回本品的程序。