Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottles (NDC 0378-6322-05), 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 160/12.5 mg in two bottle sizes (90-count and 500-count) because FDA analysis found trace amounts of an impurity called N-nitrosodiethylamine (NDEA) 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 approximately 50,595 bottles involved across specific lot numbers: 2008880, 3084358, 3084359, 3084361, and 3093801.
The source document does not specify a remedy or instructions for what consumers should do regarding this recall.
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: 50,595 HDPE bottles Lot/code info: Lot numbers: 2008880 3084358 3084359 3093801 3084359 3084361 3093801
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.