JOIN US"Ranbaxy Europe has initiated the select batch recall of three products: two in the UK and Denmark, and one in Ireland. The recall is being carried out as patient information leaflets needs to be updated, to include safety warnings initiated by the European Medicines Agency," Ranbaxy said in a statement.
The process is being undertaken in consultation and agreement with the competent authorities. There are no product quality concerns, the company said. According to the information available on the UK health regulator's website, the company is recalling three batches of anti-depressant drug Mirtazapine tablets in 15 mg strengths.
Besides this, the company has already recalled all unexpired stock of Sertraline Tablets 50 mg and 100 mg for the same reason.However, the details regarding the third drug recalled by the firm couldn't be obtained. Also, details on product recalls in Ireland and Denmark weren't available.
The company said, "To ensure effective, corrective and preventive action, the company is conducting a comprehensive review, in consultation with the authorities."The European market contributed about USD 67 million, or about 12 per cent of the company's consolidated sales, in the quarter ended March 31, 2010.The company, however, declined to comment on the impact of the recall on its earnings, but according to industry experts, "it will be negligible."
Last month US subsidiary of Ranbaxy Laboratories had recalled two lots of an antibiotic drug from the American market after receiving certain complaints about them.
Earlier in July last year, on recommendations of the US FDA, Ranbaxy had recalled a single lot of Sotret Isotretinoin capsules in 40 mg strength, used in the treatment of acne (a type of skin disease) from the US market.
The Gurgaon-based company is yet to sort out issues with the US FDA regarding good manufacturing-practices compliance of its two units located in Dewas, Madhya Pradesh and Paonta Sahib, Himachal Pradesh.