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Ranbaxy Ltd has been asked by the UK Medicines and Healthcare products Regulatory Agency (MHRA), the largest drug regulator in Europe, to recall its drugs used to treat skin infections.
Ranbaxy (UK) Ltd was recalling all unexpired stock of Isotretinoin 20mg capsules due to a potential issue with bio-equivalence in comparison with the originator product, UK MHRA said in its notification. The European Commission has also decided to suspend marketing authorisation for Isotretinoin as a temporary measure.
A company spokesperson refused to comment.
In 2009, Ranbaxy had to recall about 4,000 cartons of Sotret Isotretinoin through its US-based subsidiary, Ranbaxy Laboratories Inc, after the US Food and Drug Administration issued a ‘nation-wide class-III recall’ for a batch of capsules of 40mg. The company recalled the products after reports suggested that the product may exceed impurity specifications during its shelf life period.
Last year, it recalled a batch of Gabapentin 100mg capsules, after UK MHRA found that the patient information leaflet had not been updated to include safety warnings initiated by the European Medicines Agency. It also recalled batches of Mirtazapine 15mg and 45mg tablets and unexpired stock of Sertraline 50mg and 100mg tablets on the same ground.