Two injected drugs manufactured by an Indian company with a history of sterility problems are being recalled because of microbial contamination. The drugs were both manufactured by Emcure Pharmaceuticals but are distributed in the U.S. by Heritage Pharmaceuticals.
East Brunswick, New Jersey-based Heritage Saturday issued the voluntary recall to the consumer level for sublots of infection fighter amikacin sulfate injection and schizophrenia drug prochlorperazine edisylate after microbial growth was found in unreleased supplies of the products.
The company warned that patients injected with either of the drugs could get site-specific or even systemic infections that could lead to hospitalization and death. The company said no adverse reactions have been reported so far.
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Amikacin sulfate injection is for the short-term treatment of serious infections from a variety of species of gram-negative bacteria. Prochlorperazine edisylate injection is indicated to control severe nausea and vomiting and for the treatment of schizophrenia.
The recall does not say which Emcure facility manufactured the products. In 2015, the FDA banned nearly all products coming out of Emcure's sterile manufacturing plant in Hinjawadi, India, and then followed up with a warning letter for the facility. The agency whipped the drugmaker for routinely using "fraudulent" test data to move drugs through the manufacturing process.
The agency then patted the company on the back for turning to consultants to help it solve its problems and changing some procedures and retraining employees. However, the FDA pointed out the facility should have known better because it had been previously warned about practices that could lead to drug contamination.
Emcure also has operations in Canada, having acquired Ottawa-based International Pharmaceutical Generics and its marketing operation Marcan Pharmaceuticals in 2016.
由于微生物污染，一家印度公司生产的两种有无菌历史的注射药物被召回。这两种药物均由 Emcure Pharmaceuticals 生产，但在美国由 Heritage Pharmaceuticals 分销。位于新泽西州东不伦瑞克市的 Heritage 周六宣布，在产品的未释放供应品中发现微生物生长后，主动召回感染斗士硫酸阿米卡星注射液和精神分裂症药物乙二磺酸丙氯拉嗪的子批次至消费者水平。该公司警告说，注射这两种药物的患者可能会出现部位特异性甚至全身性感染，从而导致住院和死亡。该公司表示，目前尚未有不良反应报告。像这样的免费每日通讯？订阅 FiercePharma！生物制药是一个快速增长的世界，每天都有大的想法出现。我们的订户依靠 FiercePharma 作为最新的新闻、分析和数据的必读来源，以及制药公司。今天注册，以获得医药新闻和更新交付到您的收件箱和阅读的走。SUBSCRIBE NOW RELATED：FDA 谴责印度 Emcure 的常规伪造数据硫酸阿米卡星注射液是用于短期治疗来自多种革兰氏阴性菌的严重感染。丙氯拉嗪乙二磺酸盐注射液适用于控制严重恶心和呕吐，以及治疗精神分裂症。召回没有说明是哪家 Emcure 工厂生产产品。2015 年，FDA 禁止了几乎所有从 Emcure 位于印度 Hinjawadi 的无菌制造厂出来的产品，然后对该工厂发出警告信。该机构鞭策制药商经常使用“欺骗性的”测试数据来使药物通过生产过程。该机构随后指责该公司求助于顾问来帮助其解决问题，并改变了一些程序，对员工进行了再培训。然而，FDA 指出，该机构应该知道得更清楚，因为它之前已经被警告过可能会导致药物污染的做法。Emcure 在加拿大也有业务，2016 年收购了总部位于渥太华的国际医药仿制药及其营销业务 Marcan Pharmaceuticals
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