Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-547-90.
Check against the official notice below — it lists the full affected range.
Aurobindo Pharma USA Inc. is recalling Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg in 90-count bottles due to the presence of an impurity called N-nitrosodimethylamine (NDEA) found in the active pharmaceutical ingredient at levels above the interim acceptable daily intake limit of 0.083 parts per million. The affected product includes 32,160 bottles distributed across 25 distributors and retail chains nationwide, with lot numbers HVSA17011-A, HVSA17012-A, and HVSA18001-A, all with expiration dates between November and December 2020.
The recall source does not specify a remedy or instructions for affected consumers.
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: 32,160 bottles Lot/code info: Lot # HVSA17011-A, exp. date 11/2020 Lot # HVSA17012-A, exp. date 11/2020 Lot # HVSA18001-A, exp. date 12/2020
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.