Canada-based multinational pharmaceutical company Apotex Inc. has informed a local pharmaceutical importer that it has decided to withdraw Batch No. PY1904 of its psychiatric drug Apo-Amitriptyline 10mg tablets from the local market, according to a statement by the Pharmaceutical Supervision and Administration Bureau (ISAF) on Friday.
The statement noted that as the batch of the drug was found to contain an excessive amount of N-Nitroso-dimethylamine (NDMA), the manufacturer voluntarily recalled the problematic product from the market as a precautionary measure.
According to the US Environmental Protection Agency (EPA), NDMA, a member of N-ni- trosamines belonging to a family of potent carcinogens, is a semi-volatile organic chemical that forms in both industrial and natural processes.
The statement said that the medicine containing amitriptyline is a prescription drug used to treat depression, adding that the batch of the drug was supplied to two local hospitals, which have been informed of the recall of the drug and ordered to immediately stop using the problematic product.
The statement stressed that the bureau will continue to pay close attention to the matter.
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This undated handout photo provided by the Pharmaceutical Supervision and Administration Bureau (IASF) on Friday shows a bottle of Apo-Amitriptyline 10mg tablets.
