Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5813-77.
Check against the official notice below — it lists the full affected range.
Mylan Laboratories Limited has recalled Valsartan Tablets, USP 80 mg in 90-count bottles manufactured in India for Mylan Pharmaceuticals, Inc. The recall was initiated because FDA analysis found trace amounts of N-nitrosodiethylamine (NDEA), an impurity, in the active pharmaceutical ingredient used to manufacture the product. The affected product was distributed throughout the United States and Puerto Rico to major distributors, with 119,761 HDPE bottles involved in the recall across six lot numbers: 3065445, 3074880, 3074883, 3086688, 3086689, and 3086710.
The recall notice does not specify a remedy or recommended consumer action.
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: 119,761 HDPE bottles Lot/code info: Lot Numbers: 3065445, 3074880, 3074883, 3086688, 3086689, 3086710
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.