Recalled iron injection: FDA receives 467 vials
A batch of the drug manufactured by Pune pharmaceutical firm Emcure was recalled after a 55-year-old Mumbai-based patient died on October 12 at Saifee Hospital on developing a suspected adverse reaction.
Recalled iron injection: FDA receives 467 vials | File Photo
Within days of recalling a batch of Orofer FCM (ferric carboxymaltose), an iron supplement injection, the Food and Drug Administration (FDA) department of Maharashtra received 467 vials until Nov 24 from distributors, wholesalers and retailers.
A batch of the drug manufactured by Pune pharmaceutical firm Emcure was recalled after a 55-year-old Mumbai-based patient died on October 12 at Saifee Hospital on developing a suspected adverse reaction. The FDA has appealed to everyone to send back the leftover stock of the batch without selling or using it.
An official said a complaint was received against batch number ELF8BB2001, manufactured in 05/2022 with an expiry date of 04/2025. Taking immediate notice of the demand for a probe from the kin of the deceased, the FDA took a non-medicinal sample for testing and analysis from the stock available (seven vials) at the hospital, the official added.
FDA officials said though Emcure Pharmaceuticals is based in Pune, production takes place in MIDC, Tarapur, and Boisar; Pune is only a distribution hub. The official said, “Instructions were given to the firm to stop sale and distribution of the said drug and take back the stock from the market. Also, samples of this batch have been taken from Navi Mumbai and Pune and sent to the drug control laboratory for testing on priority basis. The drug controller was also informed about the recall action.”
An FDA official from Mumbai said the drug is used to treat iron deficiency (anaemia; lower than normal red blood cells) in adults who cannot either tolerate oral iron supplements or couldn’t be successfully treated with them.
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