Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles (NDC 0378-6325-05), 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 320/25 mg in two package sizes: 90-count bottles (NDC 0378-6325-77) and 500-count bottles (NDC 0378-6325-05). The recall was initiated 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. The affected product was distributed throughout the United States and Puerto Rico, and the recall involves 32,284 HDPE bottles across lot numbers 3084860, 3084861, 3084862, 3093804, and 3084863.
The source document does not specify a remedy or recommended action for affected consumers.
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: 32,284 HDPE bottles Lot/code info: Lot numbers: 3084860 3084861 3084862 3093804 3084862 3084863
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.