争议事件
以下收录公开来源中与该品牌相关的争议事件。列出一条并不表示过错已经证实。
返回词条共 1 条
2019
Amneal因可能含有NDMA杂质召回雷尼替丁产品
宣布召回
Amneal Pharmaceuticals自愿在消费者层面召回部分雷尼替丁片剂和糖浆，原因是产品可能含有超过FDA规定水平的NDMA。报道指出，尚无经确认与此次召回直接相关的不良事件。
品牌回应
召回 — Amneal Pharmaceuticals
Amneal Pharmaceuticals has issued a voluntary recall of its ranitidine tablets, 150 mg and 300 mg, as well as ranitidine syrup (ranitidine oral solution, USP), 15 mg/mL.
来源摘录
Amneal Pharmaceuticals has issued a voluntary recall of its ranitidine tablets, 150 mg and 300 mg, as well as ranitidine syrup (ranitidine oral solution, USP), 15 mg/mL, to the consumer level, according to a company announcement.
The recall is due to potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall.