Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90
Check against the official notice below — it lists the full affected range.
Aurobindo Pharma USA Inc. is recalling Valsartan Tablets USP 160 mg in 90-count bottles (a prescription blood pressure medication) because FDA analysis found trace amounts of N-nitrosodiethylamine (NDEA), an impurity in the active ingredient used to manufacture the product. The affected product was distributed to major distribution chains throughout the United States and includes multiple lot numbers with expiration dates ranging from January 2020 to April 2020.
The source document does not specify what remedy consumers should pursue.
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 to major distribution chains throughout the United States. Quantity: N/A Lot/code info: Lot Numbers: 472180001A, 472180002A, 472180003A, 472180004A, exp. date Jan 2020; 472180007A, 472180008A, 472180009A, 472180010A, exp. date Mar 2020; 472180013A, 472180014A, exp. date Apr 2020
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.