The Food and Drug Administration, Maharashtra has issued a circular to recall the injection Orofer FCM manufactured by Emcure Pharmaceuticals Limited, from the country, after a person died of a suspected adverse reaction to it at Saifee Hospital, Charni Road.

According to FDA officials, the 55-year-old man lost his life in October. The family of the deceased filed a complaint with the FDA and asked for an investigation. An FDA official from Mumbai said, “The FDA headquarters received a complaint on November 4 in which the complainant said that her husband lost his life on October 12 after a suspected adverse drug reaction. The patient was given Orofer FCM (Ferric Carboxymaltose Injection 500 mg/10 ml) to treat anemia. On November 10 our drug inspector visited Saifee Hospital and took the remaining 7 vials for testing. The Pune FDA has collected samples from the same batch, we expect a report within 2 weeks.”