The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public that the Health Sciences Authority (HAS) of Singapore has announced the recall of eight (8) batches of Apo-Amitriptyline 10mg and three (3) batches of Apo-Amitriptyline 25mg tablets, 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.
Product Details
The details of the affected batch of products are as follows.
Product Name | Product Manufacturer | Batch Number |
Apo-Amitriptyline 10mg Tablet
|
Pharmaforte Singapore Pte Ltd | RR0266, RV1644, RV1645 RW8598, TA6008, TF8585 TF8588, TF8589 |
Apo-Amitriptyline 25mg Tablet | TA6062, TF8602, TF8603 |
Please note that these products are not registered with NAFDAC.
Importers, distributors, retailers, healthcare professionals, and caregivers are hereby advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of counterfeit products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, or call NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng
NAFDAC………. Customer-focused, Agency-minded!!!
