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太阳制药的争议事件

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 3 条

  1. 2020

    DUSA就药品推广指控与美国司法部达成和解

    和解

    Sun Pharmaceutical Industries的全资子公司DUSA Pharmaceuticals与美国司法部达成民事和解，同意支付2,075万美元，以解决有关推广LEVULAN KERASTICK和BLU-U的指控。和解不构成承认责任或不当行为。

    来源摘录

    • Under the civil settlement agreements signed with the DOJ, DUSA will pay US$20.75 million to resolve allegations related to the promotion of LEVULAN KERASTICK and BLU-U .
    • DUSA Pharmaceuticals Inc., a wholly owned subsidiary of Sun Pharmaceutical Industries Inc. announced that it has reached a resolution with the United States Department of Justice (DOJ) concerning the promotion of LEVULAN KERASTICK (aminolevulinic acid HCL) and BLU-U.
    • The settlement does not constitute any admission by DUSA of any liability or wrongdoing.
    来源

  2. 2020

    Sun Pharma召回一批Riomet ER

    宣布召回

    Sun Pharmaceutical Industries Inc表示，因NDMA含量超过允许的每日摄入限值，在美国自愿召回一批Riomet ER口服混悬液。公司称尚未收到与此次召回相关的不良事件报告。此次召回为自愿性质，仅涉及该口服混悬液产品的一个批次。

    品牌回应

    • 召回 — Sun Pharmaceutical Industries Inc

      Sun Pharmaceutical Industries Inc, a wholly-owned subsidiary of Sun Pharmaceutical Industries, is voluntarily recalling one lot of Riomet ER (metformin hydrochloride for extended-release oral suspension) 500 mg per 5 mL to the consumer level

    来源摘录

    • The US arm of domestic pharma major Sun Pharma has said it is voluntarily recalling one lot of Riomet ER oral suspension in the US market, due to the presence of a probable human carcinogen above the acceptable daily intake limit.
    • "The reason for the recall is due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the allowable acceptable daily intake (ADI) limit established by the USFDA," it added.
    • To date, the company has not received any reports of adverse events related to this recall, it added.
    来源

  3. 2020

    Sun Pharma因NDMA杂质在美国召回RIOMET ER药品

    宣布召回

    Sun Pharmaceutical Industries通过其美国子公司在美国召回747瓶RIOMET ER，原因是成品药中检出NDMA杂质。美国监管机构将其列为II类召回。

    品牌回应

    • 召回 — Sun Pharmaceutical Industries

      The company initiated the recall on September 23, the USFDA said.

    来源摘录

    • The company initiated the recall on September 23, the USFDA said.
    • As per the USFDA, the company is recalling the product due to deviation from the current good manufacturing practices (CGMP) -- detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
    • Leading drug maker Sun Pharma is recalling 747 bottles of generic diabetes drug in the US due to possibility of the affected lot containing cancer causing nitrosodimethylamine (NDMA) above the acceptable intake limit, the US health regulator has said.
    来源