Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-573-90
Check against the official notice below — it lists the full affected range.
Aurobindo Pharma USA Inc. is recalling Valsartan Tablets USP 320 mg in 90-count bottles distributed throughout the United States. The recall was issued because the FDA found trace amounts of N-nitrosodiethylamine (NDEA), an impurity, in the active pharmaceutical ingredient used to manufacture the product. The affected lot numbers are 473180004A and 473180005A (expiration date February 2020), 473180006A (expiration date March 2020), 473180016A and 473180017A (expiration date May 2020), and 473170019A (expiration date October 2019).
The source document does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Reason for recall: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. Distribution: Product was distributed to major distribution chains throughout the United States. Quantity: N/A Lot/code info: Lot Numbers: 473180004A, 473180005A, exp. date Feb 2020; 473180006A, exp. date Mar 2020; 473180016A, 473180017A, exp. date May 2020; 473170019A, exp. date Oct 2019
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.