Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-738-30.
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/320 mg in 30-count bottles (NDC 65862-738-30) due to the presence of an impurity called N-nitrosodimethylamine (NDEA) in the active pharmaceutical ingredient. The FDA confirmed that NDEA levels in the product exceed the interim acceptable daily intake level of 0.083 parts per million. The recall affects approximately 27,688 bottles across five lot numbers (VMSA17012-A through VMSA17017-A, all expiring in November 2019) that were distributed to 25 distributors and retail chains throughout the United States.
The source document does not specify what consumers should do if they have this medication.
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: 27,688 bottles Lot/code info: Lot # VMSA17012-A, exp. date 11/2019 Lot # VMSA17013-A, exp. date 11/2019 Lot # VMSA17014-A, exp. date 11/2019 Lot # VMSA17015-A, exp. date 11/2019 Lot # VMSA17016-A, exp. date 11/2019 Lot # VMSA17017-A, exp. date 11/2019
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.