Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-573-90.
Check against the official notice below — it lists the full affected range.
Aurobindo Pharma USA Inc. is recalling Valsartan tablets USP 320 mg in 90-count bottles (NDC 65862-573-90) due to the presence of an impurity called N-nitrosodimethylamine (NDEA) in the active pharmaceutical ingredient. FDA lab testing confirmed that the NDEA levels in the recalled product exceed the interim acceptable daily intake limit of 0.083 parts per million. The recall affects 20,604 bottles from two lots: Lot # VUSD17008-A (expiration date 07/2019) and Lot # VUSD17009-A (expiration date 09/2019).
The recalled product was distributed to 25 distributors and retail chains throughout the United States, which may have distributed it further. 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.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Reason for recall: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. Distribution: Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States. Quantity: 20,604 bottles Lot/code info: Lot # VUSD17008-A, exp. date 07/2019 Lot # VUSD17009-A, exp. date 09/2019
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.