On July 13, 2018, the U.S. Food and Drug Administration issued an alert of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. According to the FDA, the presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured. Also per the FDA’s latest update today, “Based on records from the manufacturer of the recalled valsartan, some levels of the impurity may have been in the valsartan-containing products for as long as four years.”
FDA continues to evaluate the safety of valsartan-containing products and will update the list of products included in the recall and the list of products not included in the recall as more information becomes available. If you are taking any valsartan product, be sure to check to back as the lists may change.
About Borgess Law:
Attorney Pamela A. Borgess, the founder of Borgess Law, LLC, has extensive experience with numerous national high-profile defective medical drug/device cases, including representing individuals injured by contaminated prescription drugs. For more information about Valsartan recall, contact Borgess Law at (567) 455-5955. You can also contact Borgess Law by submitting an online inquiry. Borgess Law never charges for initial consultations. We welcome any questions you may have.
(You should not rely on this blog for medical advice, but instead should consult your healthcare provider for any medical advice.)