The National Agency for Food and Drugs Administration and Control (NAFDAC) has alerted the public that the Taiwan Food and Drug Administration (FDA) ordered the recall of six million tablets from two batches of Norvasc 5mg tablets produced by U.S.-based drug developer Viatris Inc., following the discovery of iron wires in samples taken from the shipment.
In a public alert notice on its Twitter handle, NAFDAC said that the Taiwan’s Consumers’ Foundation has also received complaints from long-term local Norvasc users, claiming they found iron wires inside the drug when they cut the tablets in halves.
“The major ingredient in Norvasc 5mg tablets is amlodipine besylate, which is used to treat high blood pressure or angina as it inhibits the movement of calcium ions across cardiac muscle and the smooth muscle lining of blood vessels,” NAFDAC said.
According to the alert notice, the Norvasc that is being recalled is the 5mg tablets manufactured by Viatris Inc, USA with Batch Number FR3135 and FT2343 with amlodipine besylate as an active pharmaceutical ingredient.
NAFDAC implored importers, distributors, retailers, and consumers to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of the affected batches of the product. It advised that l medical products be obtained from authorized/licensed suppliers and that the products’ authenticity and physical condition be carefully checked.
NAFDAC also advised members of the public in possession of the above-listed products to discontinue sale or use and submit stock to the nearest NAFDAC office.
“If you have these batches of products, please DO NOT use them. If you, or someone you know, have used these products or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional,” NAFDAC said.
“Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office on: 0800-162-3322 or via email: [email protected].
“Similarly, Healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal product 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 [email protected],” it said.
