FDA Maharashtra recalls Pune company’s injection from across the country

A patient died after he was injected Orofer FCM manufactured by Emcure Pharmaceuticals Ltd; his family sought an investigation

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.”

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S B Patil, joint commissioner FDA, Pune said, “The injection was manufactured by Emcure Pharmaceuticals  a Pune-based company, the production took place in MIDC, Tarapur, Boisar. We have informed all the states to stop the use of this drug and have asked for its recall from the market.” 

Emcure Pharmaceuticals in a statement said, “The matter is under investigation and we are co-operating with the authorities. We had also earlier filed complaints regarding counterfeit products with various authorities including FDA and police, as we learnt of ADR incidents due to counterfeit products in the market. As an abundance of precaution and at the direction of the authorities, we are recalling the mentioned batch, even though our product is of standard quality.” Despite repeated attempts to contact officials, there was no response from Saifee Hospital.

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