Hyderabad: Pfizer recalled Citalopram tablets, manufactured by city-based Aurobindo Pharma, from the US market owing to wrong labelling, the pharma major has said in a filing with the US health regulator.
The latest recall, which was notified by the US FDA on 17 August, involved 720 units of Citalopram tablets, USP, 10 mg, 100-count bottles.
“Label Mix-Up; Bottles of finasteride 5 mg tablets (90-count) have been found to be incorrectly labelled as citalopram 10 mg (100-count) tablets. The lot number, FI0510058-A, appears on both the citalopram 10 mg labels and the finasteride 5 mg labels,” the US FDA said while stating the reason for recall.
Earlier, the US FDA had imposed an import alert on the drugs manufactured at Unit-III and VI of the Aurobindo Pharma’ plant in Hyderabad, for inadequate labeling system and for not meeting certain prescribed standards.