Public Alert No. 010/2023 – Alert on Recall of Two lots of Norvasc 5mg Tablets
March 28, 2023,
The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying 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.
According to Taiwan’s Consumers’ Foundation, complaints have also been received 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.
The details of the product are as follows;
Product Name: Norvasc 5mg tablets
Product Manufacturer: Viatris Inc.,USA
Batch Number: FR3135 and FT2343
Active pharmaceutical ingredient: Amlodipine besylate
NAFDAC implores 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. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Members of the public in possession of the above listed products are advised 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.
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: firstname.lastname@example.org
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@example.com