467 vials of Orofer FCM returned, says FDA

Mumbai: Six days after an urgent order to recall Orofer FCM, an iron supplement given to patients to increase haemoglobin, manufactured by Emcure Pharmaceuticals Ltd from across the country was issued, the Food and Drugs Administration (FDA) said it has collected 467 vials of the injection

Mumbai: Six days after an urgent order to recall Orofer FCM, an iron supplement given to patients to increase haemoglobin, manufactured by Emcure Pharmaceuticals Ltd from across the country was issued, the Food and Drugs Administration (FDA) said it has collected 467 vials of the injection.

HT Image

The FDA had issued the order on the basis of a complaint filed by the wife of a 55-year-old patient, who had died of suspected adverse drug reaction at Saifee Hospital, Charni Road, a month ago. The deceased had gone to the outdoor patient department of the hospital and was reportedly administered Orofer FCM (ferric carboxymaltose) after which he had an anaphylactic reaction. His blood pressure dropped suddenly and the airways narrowed, which led to breathing issues and he died soon after.

The hospital administration claimed that it had reported the death due to adverse drug reaction to the Central Drugs Standard Control Organisation.

On Saturday, the FDA released a statement stating that they have got 467 vials back from the market till November 24.

In the statement, the FDA once again appealed to the wholesalers, retailers and hospitals to return the drug stock of the said batch to the supplier without selling or using it.

“We have given the vials procured from Saifee Hospital for testing and analysis along with the stock we got from the two warehouses of the manufacturer in Navi Mumbai and Pune. We have instructed everyone to stop the supply and distribution of the drug and take back the stock from the market,” an FDA official said.

An Emcure spokesperson had earlier stated, “The matter is under investigation. We had earlier filed complaints regarding counterfeit products with various authorities, including FDA and the police, as we learnt of incidences of adverse drug reaction due to counterfeit products in the market.”