Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-739-30.
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/160 mg in 30-count bottles (NDC 65862-739-30) because the FDA confirmed the presence of an impurity called N-nitrosodimethylamine (NDEA) in the active pharmaceutical ingredient at levels above the acceptable daily intake limit of 0.083 parts per million. A total of 60,417 bottles across 13 specific lot numbers with expiration dates ranging from May 2019 through March 2020 were distributed to 25 distributors and retail chains throughout the United States.
The recall record does not specify what actions consumers should take regarding this product.
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: 60,417 bottles Lot/code info: Lot # VFSA17008-A, exp. 10/2019 Lot # VFSA17010-A, exp. 10/2019 Lot # VFSA18002-A, exp. 01/2020 Lot# VFSA18003-A, exp. 01/2020 Lot # VFSA18007-A, exp. 03/2020 Lot # VFSA18008-A, exp. 03/2020 Lot # VKSA17008-A, exp. 05/2019 Lot # VFSA17009-A, exp. 10/2019 Lot # VKSA17014-A, exp. 10/2019 Lot # VKSA17015-A, exp. 10/2019 Lot # VKSA17016-A, exp. 10/2019 Lot # VKSA17017-A, exp. 10/2019 Lot # VKSA18002-A, exp. 01/2020 Lot # VKSA18004-A, exp. 01/2020
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.