Company-led drug recall：Isotretinoin 20mg capsules - Ranbaxy (UK) Limited

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Company-led drug recall: Isotretinoin 20mg capsules - Ranbaxy (UK) Limited
CLDA number: CLDA(11)A/08

MDR number: MDR 02-06/11

Company name: Ranbaxy (UK) Limited

Product description: Isotretinoin 20mg capsules (PL 14894/0162)

Batch number: All unexpired stock

Brief description of problem: Ranbaxy (UK) Limited is recalling all unexpired stock of this product following a decision made by the European Commission that the marketing authorisation should be suspended as a temporary measure. This is due to a potential issue with bioequivalence in comparison with the originator product.
Company contact for stock enquiries: 020 8742 5299

Company contact for medical information enquiries: 020 8742 5292

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主动召回：异维A酸胶囊20mg-南新（英国）公司
CLDA编号: CLDA(11)A/08
MDR编号: MDR 02-06/11
公司名称: Ranbaxy (UK) Limited南新（英国）公司
产品描述:异维A酸胶囊20mg (PL 14894/0162)
批号: 所有效期内库存产品
问题简述: 南新（英国）公司之所以在EC发布了一项临时措施，暂停销售权后，召回所有效期内库存本品，是因为该产品被认为与原研产品相比可能具有生物等效性的潜在问题。
公司库存联系电话: 020 8742 5299
公司医学信息联系电话: 020 8742 5292