Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-1721-93.
Check against the official notice below — it lists the full affected range.
Mylan Laboratories Limited is recalling Amlodipine and Valsartan Tablets USP 5/160 mg in 30-count bottles manufactured in India for Mylan Pharmaceuticals, Inc. The recall affects approximately 141,995 bottles distributed throughout the United States and Puerto Rico. The tablets were recalled because FDA analysis confirmed the presence of trace amounts of N-nitrosodiethylamine (NDEA), an impurity found in the active pharmaceutical ingredient used to manufacture the product, which represents a deviation from good manufacturing practices.
The affected lot numbers are 3064084, 3069629, 3073148, 3073149, 3076093, and 3077772. The source document does not specify what remedy or action affected consumers 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: 141,995 HDPE bottles Lot/code info: Lot Numbers:3064084, 3069629, 3073148, 3073149,3076093, 3077772
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.