Mylan Recalls All Lots of Its Valsartan-Containing Products
December 4, 2018 – Mylan has voluntarily recalled all lots of its valsartan-containing products within expiry. The valsartan active pharmaceutical ingredient (API) in these products contains trace amounts of NDEA (N-Nitrosodiethylamine).
A probable human carcinogen (cancer-causing agent), NDEA occurs naturally in certain foods, drinking water, air pollution, and industrial processes. The affected valsartan API was manufactured by Mylan Laboratories Limited.
Patients who have been taking the affected medications should continue to do so until they have consulted with their pharmacist or prescriber about switching to an alternative. Stopping the affected medication before switching to an alternative can put patients at risk, as valsartan-containing products are used to treat serious medical conditions such as heart disease.
Mylan is working to notify distributors and customers of the recall by letter. The company has directed consumers who are in possession of any of the recalled products to contact Stericycle at 1-888-406-9305 (Monday-Friday, 8:00am to 5:00pm EST) to arrange returns. Patients should contact their prescribers if they experience any adverse events. Adverse events that may be related to use of the recalled products can also be reported to the FDA’s MedWatch program.
A full list of affected products can be found at:
BeneCard PBF’s mail order pharmacy, Benecard Central Fill, experienced minimal impact from the recall.