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Mumbai: FDA boss bats for change in system to recall drugs

Agency’s efforts call back a particular injection, following a patient’s death due to suspected adverse drug reaction, get poor response

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Emcure’s Orofer FCM (ferric carboxymaltose 500 mg/10 ml) is given to patients to increase haemoglobin

Emcure’s Orofer FCM (ferric carboxymaltose 500 mg/10 ml) is given to patients to increase haemoglobin

Maharashtra's Food and Drug Administration officials have expressed dismay after the agency’s efforts to pull back an injection from the market elicited a poor response, stressing that it was time to change the system of recalling drugs. Six days ago, the FDA ordered that Orofer FCM (ferric carboxymaltose 500 mg/10 ml), given to patients to increase haemoglobin, be recalled following a death due to a suspected adverse drug reaction.

So far, only 4 per cent of the 11,000 vials in the state have come back to the FDA.

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