Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30
Check against the official notice below — it lists the full affected range.
Aurobindo Pharma USA Inc. is recalling Amlodipine and Valsartan Tablets USP 5 mg/160 mg in 30-count bottles because the FDA confirmed the presence of an impurity called N-nitrosodimethylamine (NDEA) in the active pharmaceutical ingredient at levels above the interim acceptable daily intake limit of 0.083 parts per million. The affected product was manufactured for Aurobindo Pharma USA, Inc. in Dayton, New Jersey, and includes four specific lots with expiration dates between October 2019 and December 2019; approximately 18,408 bottles were distributed to 25 distributors and retail chains across the United States.
The source document does not specify what actions 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: 18,408 bottles Lot/code info: Lot # VESA17013-A, exp. 10/2019 Lot # VESA17014-A, exp. 10/2019 Lot # VESA18001-A, exp. 12/2019 Lot # VESA18002-A, exp. 12/2019
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.