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Ranbaxy is recalling all unexpired stock of anti-acne product isotretinoin (20mg capsules) in the UK, according to the UK Medicines and Healthcare Products Regulatory Agency's (MHRA).
Isotretinoin is the generic version of Hoffman La Roche's product sold under the brand name Accutane.
A statement on the MHRA Web site said that Ranbaxy (UK) Ltd was 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, the note said.
Ranbaxy did not comment on the recall or the impact it would have on the company's performance. The company at present already faces regulatory issues raised in 2008 by the US regulatory authority regarding two of its India plants.
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