Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-740-30.
Check against the official notice below — it lists the full affected range.
Aurobindo Pharma USA Inc. is recalling Amlodipine and Valsartan Tablets USP 10 mg/320 mg in 30-count bottles (NDC 65862-740-30) because the FDA lab confirmed the presence of an impurity called N-nitrosodimethylamine (NDEA) in the active pharmaceutical ingredient at levels exceeding the interim acceptable daily intake limit of 0.083 parts per million. The recall affects 55,788 bottles from two lots: Lot # VKSA18005-A (expiration date 03/2020) and Lot # VKSA18001-A (expiration date 01/2020), which were distributed to 25 distributors and retail chains throughout the United States.
The source document does not specify a remedy or instructions for affected consumers 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: 55,788 bottles Lot/code info: Lot # VKSA18005-A, exp. date 03/2020 Lot # VKSA18001-A, exp. date 01/2020
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.