FDA-Drug2019-03-27Class II
Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90
Aurobindo Pharma USA Inc.
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.
Sold states
Product was distributed to major distribution chains throughout the United States.
Affected count
N/A
Manufactured in
279 Princeton Hightstown Rd, N/A, East Windsor, NJ, United States
Products
Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1038-2019Don't want to check this manually?
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