Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottles (NDC 0378-6321-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
Check against the official notice below — it lists the full affected range.
Mylan Laboratories Limited is recalling Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg in both 90-count bottles (NDC 0378-6321-77) and 500-count bottles (NDC 0378-6321-05) manufactured at its Nashik facility. The FDA confirmed the presence of trace amounts of N-nitrosodiethylamine (NDEA), an impurity found in the active pharmaceutical ingredient used to make the product. The affected lot numbers are 3084363, 3084364, 3093800, and 3093800, with a total of 32,696 bottles distributed throughout the United States and Puerto Rico to major distributors.
The recall notice does not specify a remedy or instructions for affected consumers regarding what action they should take.
Written by software from the official notice below. Not reviewed by a lawyer.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Reason for recall: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. Distribution: Product was distributed throughout the United States to several major distributors, including Puerto Rico. Quantity: 32,696 HDPE bottles Lot/code info: Lot numbers: 3084363, 3084364, 3093800, 3084363, 3093800
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.