New Delhi: Drug firm Ranbaxy Laboratories is recalling all unexpired stock of Isotretinoin 20-mg capsules, used in the treatment of severe skin conditions, from the UK market following a directive from the European Commission.
As per a statement on the UK Medicines and Healthcare Products Regulatory Agency’s (MHRA) website, the company’s UK arm, Ranbaxy (UK) Ltd, is recalling all unexpired stock of this product following a decision made by the European Commission that the marketing authorization should be suspended as a temporary measure.
“This is due to a potential issue with bioequivalence in comparison with the originator product,” the statement added.
Industry sources believe that the recall is temporary, with no safety or quality concerns involved. When contacted, company officials declined comment.
The MHRA allows company-led recalls that do not result in the issue of a full-distribution drug alert.
As per the information available on the MHRA website, company-led recalls are usually seen in cases with a known and limited distribution and it is seen as beneficial not to contact large numbers of unaffected individuals.
Shares of Ranbaxy were being quoted at Rs536.30 apiece on Bombay Stock Exchange in Thursday afternoon trade, down 0.03% from their previous close.