The National Agency for Food and Drugs Administration and Control (NAFDAC) has warned the public about the recall of some batches of Apo-Amitriptyline tablets.
According to the agency, the recall, initiated by the Health Sciences Authority (HSA) of Singapore, involves eight batches of the 10mg dosage and three batches of the 25mg dosage, manufactured by Pharma Forte Singapore Pte Ltd.
“The affected batches were recalled due to the detection of Nitrosamine impurities above acceptable levels.
“Nitrosamines are chemical compounds classified as probable human carcinogens based on animal studies.
“They can occur naturally in certain foods such as cheeses, grilled meats, and vegetables, as well as in water and cosmetics. However, long-term exposure to high levels of Nitrosamine can increase the risk of cancer.
“Apo-Amitriptyline medication is typically used for depression or to assist in the treatment of pain. It may also be used for the prevention of migraines, as well as for other uses as determined by the healthcare provider,” the statement by NAFDAC reads.
Although the agency confirmed that the affected products are not registered with the agency, it urged stakeholders to exercise vigilance in the supply chain.
NAFDAC urged importers, distributors, and healthcare providers to refrain from the importation, sale, or use of unregistered and potentially substandard products.
It further urged consumers to verify the authenticity of all medical products and report any suspicious activities.
Similarly, the agency urged Healthcare professionals and patients are encouraged to report adverse effects or side effects linked to medicines or devices via NAFDAC’s e-reporting platforms or its mobile Med-Safety application, available on Android and iOS.
