Mumbai based Blue Cross Laboratories Limited, has decided to recall and destroy 50,000 units of its nimesulide paediatric suspensions drug from its branches all over the country. The company has already discontinued production of all nimesulide formulations a few months ago.
The decision to stop manufacture and sale of nimesulide paediatric suspensions comes in the wake of the move by the Drug Control General Of India (DCGI) to review the safety profile of the drug in the wake of reports of its adverse side effects amongst children.
Speaking to the Pharmabiz.com, N. H. Israni told that Blue Cross would recall Rs. 10 lakh worth of nimesulide paediatric.
Nimesulide is a nonsteroidal anti-inflammatory drug of sulfonalide class. Nimesulide decreases histamine release from tissue mast cells and inhibits the production of platelet activating factors by human basophils. The drug has not been in use in the US, Canada, Australia and some of the European countries for some years. Spain and Finland banned nimesulide last year subsequent a study by Zurich University Hospital.
Meanwhile DCGI had banned fixed dose combinations of diazepam with diphenhydramine hydrochloride some time back for its harmful effects on children.