Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5815-77.
Check against the official notice below — it lists the full affected range.
Mylan Pharmaceuticals is recalling Valsartan Tablets USP 320 mg in 90-count bottles manufactured by Mylan Laboratories Limited in Nashik, India. The FDA confirmed the presence of trace amounts of N-nitrosodiethylamine (NDEA), an impurity found in the active pharmaceutical ingredient used to manufacture the product. The affected product was distributed throughout the United States and Puerto Rico, and the recall involves 129,754 bottles across 22 specific lot numbers.
Consumers who have received this medication should check their bottle for one of the listed lot numbers. The source document does not specify what 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: 129,754 HDPE bottles Lot/code info: Lot Numbers: 3063783 3063784 3063785 3064092 3064093 3064094 3070349 3070350 3070351 3070352 3070353 3070354 3079030 3079031 3079032 3079033 3080011 3080224 3081498 3081500 3087126 3088476
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.