Viatris Inc. has voluntarily recalled telmisartan and amlodipine tablets, a prescription blood pressure medicine made for Mylan Pharmaceuticals Inc., a company associated with Viatris. The recall covers 21,620 bottles distributed nationwide. Viatris started it on Oct. 1, and the FDA has classified it as Class III, its lowest-risk tier. No injuries or illnesses have been reported.
What's Being Recalled?
The product is telmisartan 40 mg and amlodipine 5 mg tablets in 30-count bottles, NDC 0378-1075-93. The tablets were made in India for Mylan Pharmaceuticals of Morgantown, WV. Lots 3228113, 3228114 and 3228115 carry an expiration date of Oct. 31, 2026, so they are already past date. Lots 3228120 and 3228121 expire Nov. 30, 2026. Reports do not list specific retailers or states, only nationwide distribution. This medicine is available by prescription only.
Why Was This Product Recalled?
The FDA lists the reason as a superpotent drug: there is potential for the telmisartan content in these lots to exceed specifications. The agency did not say how much extra telmisartan the tablets may contain. A Class III classification means that using the product is unlikely to cause adverse health consequences. No illnesses or injuries have been reported in connection with the recall.
What Should You Do?
Check your bottle for the lot number, which is typically printed near the expiration date. If it matches one of the five lots, call your doctor or pharmacist before changing or stopping your medication. Reports on whether to stop taking it conflict, and suddenly stopping a blood pressure drug can carry its own risks, so get professional guidance first. Ask your pharmacy about a replacement or return. For questions, you can reach the FDA at 1-888-INFO-FDA (1-888-463-6332). Protecting your household's health also means protecting your wallet, so ask your pharmacist whether a replacement bottle can be provided at no extra cost.
Source:https://www.yahoo.com/news/us/articles/over-20-000-bottles-blood-151000170.html