Ranbaxy Laboratories on Wednesday said its European subsidiary is recalling select batches of three drugs, including two anti depressants, from Britain, Ireland and Denmark for updating safety warning on them.
“Ranbaxy Europe has initiated the select batch recall of three products: two in the U.K. 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 U.K. 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 $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.”