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Reddy's,Lupin博士因制造问题在美国召回产品

Dr Reddy's, Lupin recall products in US due to manufacturing issues

economictimes.indiatimes 等信源发布 2024-09-04 18:50

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Dr Reddy's Laboratories and Lupin are recalling products in the US due to manufacturing issues, as per the US Food and Drug Administration (USFDA). Dr Reddy's Laboratories Inc, a subsidiary of Hyderabad-based drug firm, is recalling Ibuprofen tablets in multiple strengths, the US health regulator said in its latest enforcement report.

据美国食品和药物管理局(USFDA)称,Reddy博士的实验室和Lupin因制造问题正在美国召回产品。美国卫生监管机构在其最新执法报告中表示,总部位于海得拉巴的制药公司的子公司Reddy博士实验室公司正在召回多种强度的布洛芬片剂。

Ibuprofen tablets are indicated for pain relief and fever. New Jersey-based Dr Reddy's Laboratories Inc. is recalling 1,03,298 bottles (800 mg); 31,802 bottles (600 mg); and 14,940 bottles (400 mg) of Ibuprofen tablets in the US market, USFDA said. The company is recalling the affected lot due to 'Failed impurities/degradation specifications,' it added.

布洛芬片剂用于缓解疼痛和发烧。;31802瓶(600毫克);美国食品和药物管理局表示,美国市场上有14940瓶(400毫克)布洛芬片剂。该公司补充说,由于“杂质/降解规格不合格”,该公司正在召回受影响的批次。

RECOMMENDEDSTORIES FOR YOU'Results for unknown impurity were 0.13 per cent and 0.11 per cent, respectively, exceeding the 0.10 per cent specification limit,' USFDA noted. The company initiated the Class II nationwide recall on August 6 this year. USFDA stated that Lupin is recalling 4,554 bottles of Cefixime for Oral Suspension in the market.

美国食品和药物管理局(USFDA)指出,推荐给你的故事(RECOMMENDEDSTORIES)“未知杂质的结果分别为0.13%和0.11%,超过了0.10%的规格限制。”。该公司于今年8月6日在全国范围内发起了二级召回。美国食品药品监督管理局(USFDA)表示,卢平正在市场上召回4554瓶头孢克肟口服混悬剂。

The US-based arm of the Mumbai-based drug maker is recalling the affected lot of the drug, used to treat bacterial infections, on account of it being 'Subpotent'. Baltimore-based Lupin Pharmaceuticals Inc. initiated the Class II recall on August 21. As per the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.(You can now subscribe to our Economic Times WhatsApp channel)(You can now subscribe to our Economic Times WhatsApp channel).

。总部位于巴尔的摩的卢平制药公司(LupinPharmaceuticals Inc.)于8月21日启动了II类召回。根据美国食品和药物管理局(USFDA)的规定,如果使用或接触违禁产品可能会导致暂时或医学上可逆的不良健康后果,或者严重不良健康后果的可能性很小,则会启动II类召回。(您现在可以订阅我们的经济时报WhatsApp频道)(您现在可以订阅我们的经济时报WhatsApp频道)。