Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-570-30
Check against the official notice below — it lists the full affected range.
Aurobindo Pharma USA Inc. is recalling Valsartan Tablets USP 40 mg in 30-count bottles distributed throughout the United States. The recall was initiated because FDA analysis found trace amounts of N-nitrosodiethylamine (NDEA), an impurity, in the active pharmaceutical ingredient used to manufacture the product. The affected lots are: 470180008A (expiration February 2020), 470180014A and 470180016A (expiration March 2020), and 470180032A (expiration May 2020).
The product was distributed to major distribution chains across the country. The recall notice does not specify a remedy or action for affected consumers to take.
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: 470180008A, exp. date Feb 2020; 470180014A, 470180016A, exp. date Mar 2020; 470180032A, exp. date May 2020
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.