Aurobindo Pharma USA Inc. recalls Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC
Recalled March 27, 2019 · FDA recall D-1039-2019 · Aurobindo Pharma USA
Hazard
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. · FDA Class II
Units
N/A
Sold at
Product was distributed to major distribution chains throughout the United States.
Description
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Product
Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90
Manufacturer(s)
Aurobindo Pharma USA Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →