Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5814-77.
Check against the official notice below — it lists the full affected range.
Mylan Laboratories Limited is recalling Valsartan Tablets, USP 160 mg in 90-count bottles manufactured in India and distributed throughout the United States and Puerto Rico. 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. A total of 232,180 HDPE bottles across 18 specific lot numbers are affected by this recall.
The affected lot numbers are: 3069019, 3069020, 3069021, 3069022, 3071354, 3071355, 3071357, 3079023, 3079027, 3079028, 3079029, 3079996, 3079997, 3079998, 3083635, 3086715, 3086716, and 3086717. The source document does not specify what action affected consumers should take 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: 232,180 HDPE bottles Lot/code info: Lot Numbers: 3069019, 3069020, 3069021, 3069022, 3071354, 3071355, 3071357 3079023 3079027 3079028 3079029 3079996 3079997 3079998 3083635 3086715 3086716 3086717 3088623
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.