The Pharmaceutical Supervision and Administration Bureau (ISAF) announced in a statement yesterday that a batch of antidepressant medication called “Apo-Amitriptyline 10mg Tab 1000’s” produced by Canadian company Apotex Inc. was found to contain excessive levels of N-nitroso Nortriptyline (NNORT).
This impurity, which exceeds the acceptable limits, poses potential health risks to patients, the statement said.
According to the UK’s National Health Service, common side effects of Nortriptyline include a dry mouth and constipation, which are usually mild and go away after a couple of weeks.
As a precautionary measure, the manufacturer has voluntarily recalled the problematic batch of medication that has been imported to Macau, the statement said.
The product in question contains amitriptyline, a prescription medication commonly used for the treatment of depression, the statement pointed out.
According to information provided by the importer, the affected batch of medication has been supplied to three local private medical institutions and clinics.
The bureau has ordered these medical institutions and clinics to cease using the affected batch of medication and instructed the importer to proceed with the recall, the statement noted.
The bureau said it will closely monitor the situation. Members of the public with any enquiries can contact the bureau during office hours on 8598 3533.
This file photo provided by the Pharmaceutical Supervision and Administration Bureau (ISAF) yesterday shows the antidepressant medication containing excessive impurities.
