The Pharmaceutical Supervision and Administration Bureau (ISAF) has warned the public about 12 batches of Apo-Amitriptyline tablets manufactured by Canadian-based Apotex Inc., following the detection of an impurity known as N-Nitrosonortriptyline (NNORT) in the product.
According to an ISAF statement on Thursday, the problematic products, a type of medicine used to treat clinical depression, include Apo-Amitriptyline Tablets in both 10mg and 25mg formulations in, respectively, RN6384!BRR0266!BRV1644!BRW8597!BTA6008!BTF8585!BTF8587 and TF8589 batches, as well as RR0781!BRW8691!BTA6062 and TF8602 batches.
The statement noted that the affected products were supplied to local health centres, private hospitals and polyclinics, adding that as a precautionary measure, it advised those who have recently been prescribed the drug to visit health centres for a replacement of the drug with the prescription issued by the bureau, while those who have obtained the product from other healthcare institutions “may seek advice from their attending doctors or pharmacists for arrangement of disposal”.
The bureau has endorsed a recall of the 12 affected batches from the drug manufacturer.
This undated handout photo provided by the Pharmaceutical Supervision and Administration Bureau (ISAF) on Friday shows two containers of the Canada-made Apo-Amitriptyline tablets in 10mg and 25mg formulations.
