NDC 65862-573

Valsartan 320 mg tablet, film coated

On the label: Aurobindo Pharma Limited.

Where it's made

Factory	Where	Role	Last FDA inspection
Aurobindo Pharma Limited	Mahabubnagar, India	Makes it and tests it	Problems found, fixed voluntarilyMay 10, 2022 · 7 inspections, 1 with FDA action
Aurolife Pharma LLC	Dayton, NJ, United States	Makes it and tests it	Serious problems, FDA actionDec 7, 2021 · 10 inspections, 1 with FDA action
Aurolife Pharma LLC	Dayton, NJ, United States	Packages it and labels it	Serious problems, FDA actionDec 7, 2021 · 10 inspections, 1 with FDA action

Recalls

Dec 31, 2018 · Class II · Aurobindo Pharma USA Inc.
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.
Lots: Lot # VUSD17008-A, exp. date 07/2019 Lot # VUSD17009-A, exp. date 09/2019
Dec 31, 2018 · Class II · Aurobindo Pharma USA Inc.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Lots: Lot Numbers: 473180004A, 473180005A, exp. date Feb 2020; 473180006A, exp. date Mar 2020; 473180016A, 473180017A, exp. date May 2020; 473170019A, exp. date Oct 2019
Dec 31, 2018 · Class II · Aurobindo Pharma USA Inc.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Lots: Lot Numbers: 470180008A, exp. date Feb 2020; 470180014A, 470180016A, exp. date Mar 2020; 470180032A, exp. date May 2020
Dec 31, 2018 · Class II · Aurobindo Pharma USA Inc.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Lots: Lot Numbers: 471170015A, exp. date Sep 2019; 471180004A, 471180005A, exp. date Feb 2019
Dec 31, 2018 · Class II · Aurobindo Pharma USA Inc.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Lots: Lot Numbers: 472180001A, 472180002A, 472180003A, 472180004A, exp. date Jan 2020; 472180007A, 472180008A, 472180009A, 472180010A, exp. date Mar 2020; 472180013A, 472180014A, exp. date Apr 2020

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug: Valsartan: every company that makes it
Form: tablet, film coated, oral
Strength: 320 mg
Approval: ANDA ANDA202223
On the market since: Jan 5, 2015
Package NDCs: 65862-573-05 65862-573-90
Official label: DailyMed (National Library of Medicine), updated May 19, 2024

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