Macau’s drug regulator has ordered the recall of several batches of antidepressant drugs produced by Canadian pharmaceutical company Apotex Inc. after the discovery of unacceptable levels of a nitrosamine impurity in some products.
The affected drugs include the antidepressant medications “Apo-Amitriptyline 10mg Tab 1000s” and “Apo-Amitriptyline 25mg Tab 1000s,” which were found to contain N-Nitrosonortriptyline (NNORT) impurities at levels exceeding acceptable levels. As a precaution, Apotex has voluntarily recalled 12 batches of the drugs imported to Macau.
The drugs were supplied to healthcare centers, private hospitals, and clinics in the region. The Institute for Pharmaceutical Supervision and Administration in Macau has instructed the importer to monitor the recall closely, while medical institutions have been directed to immediately stop using the affected batches.
The specific recalled batch numbers are:
10mg tablets: RN6384, RR0266, RV1644, RW8597, TA6008, TF8585, TF8587, TF8589
25mg tablets: RR0781, RW8691, TA6062, TF8602
Residents who recently received prescriptions for the recalled medications from public health centers should return to those centers during business hours to receive replacements. Those who obtained affected batches from other providers should consult their doctor or pharmacist.
For inquiries, the surveillance department of the Institute for Pharmaceutical Supervision and Administration can be contacted on 8598 3233 during business hours. The institute has stressed the importance of the recall and urged the public to comply. VC
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