Maharashtra FDA asks drug controller authorities to stop use of drug following patient's death

Maharashtra Food & Drug ministration (FDA) has asked all drug controller authorities in country to stop use of a particular batch of drug INJ OROFER FCM following death of a patient at a Mumbai hospital.

A person died at Saifee Hospital in Mumbai due to suspected verse drug reaction (R) of drug, said a senior official from FDA's Pune division on Wednesday.

Orofer FCM injection is used to treat iron deficiency anaemia.

Emcure Pharmaceuticals, manufacturer, was asked to recall particular batch of drug, said SB Patil, Joint Commissioner (Drugs) FDA.

death of a person at Saifee Hospital was due to suspected verse reaction of this drug, he said.

As per company, re could be spurious drugs available in market in name of INJ OROFER and because of such spurious drug suspected verse reaction might have taken place, he said.

company also told FDA that spurious versions of one of its or drugs was alrey being sold in market, he said.

"Mumbai FDA team is carrying out a probe in matter," Patil said, ding that samples from batch of drug have been collected from distributors and sent for analysis.

Emcure Pharmaceuticals said in a statement that it h earlier filed complaints with various authorities including FDA and police "as we learnt of R incidents due to counterfeit products in market." "As an abundance of precaution and at direction of authorities, we are recalling mentioned batch, even though our product is of standard quality," it said, ding that it was cooperating with authorities.