PhotoAurobindo Pharma USA is recalling 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP.

Trace amounts of an unexpected impurity, N-nitrosodiethylamine (NDEA) -- a probable human carcinogen -- were found in the finished drug product.

There are no reports of adverse events related to this recall.

The following products, which are packaged in bottles, are being recalled:


NDC
Name and strengthCountLot numberExpiry
65862-737-30Amlodipine and Valsartan Tablets USP5mg/160mg30VESA17013-A10/2019
65862-737-30Amlodipine and Valsartan Tablets USP5mg/160mg30VESA17014-A10/2019
65862-737-30Amlodipine and Valsartan Tablets USP5mg/160mg30VESA18001-A12/2019
65862-737-30Amlodipine and Valsartan Tablets USP5mg/160mg30VESA18002-A12/2019
65862-739-30Amlodipine and Valsartan Tablets USP10mg/160mg30VFSA17008-A10/2019
65862-739-30Amlodipine and Valsartan Tablets USP10mg/160mg30VFSA17010-A10/2019
65862-739-30Amlodipine and Valsartan Tablets USP10mg/160mg30VFSA18002-A01/2020
65862-739-30Amlodipine and Valsartan Tablets USP10mg/160mg30VFSA18003-A01/2020
65862-739-30Amlodipine and Valsartan Tablets USP10mg/160mg30VFSA18007-A03/2020
65862-739-30Amlodipine and Valsartan Tablets USP10mg/160mg30VFSA18008-A03/2020
65862-740-30Amlodipine and Valsartan Tablets USP10mg /320mg30VKSA17008-A05/2019
65862-740-30Amlodipine and Valsartan Tablets USP10mg /320mg30VKSA17014-A10/2019
65862-740-30Amlodipine and Valsartan Tablets USP10mg /320mg30VKSA17015-A10/2019
65862-740-30Amlodipine and Valsartan Tablets USP10mg /320mg30VKSA17016-A10/2019
65862-740-30Amlodipine and Valsartan Tablets USP10mg /320mg30VKSA17017-A10/2019
65862-740-30Amlodipine and Valsartan Tablets USP10mg /320mg30VKSA18002-A01/2020
65862-740-30Amlodipine and Valsartan Tablets USP10mg /320mg30VKSA18004-A01/2020
65862-738-30Amlodipine and Valsartan Tablets USP5mg /320mg30VMSA17012-A11/2019
65862-738-30Amlodipine and Valsartan Tablets USP5mg /320mg30VMSA17013-A11/2019
65862-738-30Amlodipine and Valsartan Tablets USP5mg /320mg30VMSA17014-A11/2019
65862-738-30Amlodipine and Valsartan Tablets USP5mg /320mg30VMSA17015-A11/2019
65862-738-30Amlodipine and Valsartan Tablets USP5mg /320mg30VMSA17016-A11/2019
65862-738-30Amlodipine and Valsartan Tablets USP5mg /320mg30VMSA17017-A11/2019
65862-739-30Amlodipine and Valsartan Tablets USP10mg/160mg30VFSA17009-A10/2019
65862-740-30Amlodipine and Valsartan Tablets USP 10mg /320mg30VKSA18005-A03/2020
65862-740-30Amlodipine and Valsartan Tablets USP 10mg /320mg30VKSA18001-A01/2020
65862-550-90Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg90HRSA17033-A10/2020
65862-550-90Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg90HRSA17034-A10/2020
65862-550-90Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg90HRSA17035-A10/2020
65862-550-90Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg90HRSA17036-A10/2020
65862-550-90Valsartan and Hydrochlorothiazide tablets & USP 320mg/12.5mg90HRSA17037-A10/2020
65862-548-90Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg90HTSA17033-A10/2020
65862-548-90Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg90HTSA17034-A10/2020
65862-548-90Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg90HTSA17035-A10/2020
65862-548-90Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg90HTSA17036-A10/2020
65862-548-90Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg90HTSA17040-A10/2020
65862-548-90Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg90HTSA17041-A11/2020
65862-548-90Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg90HTSA17042-A11/2020
65862-548-90Valsartan and Hydrochlorothiazide Tablets USP160mg/12.5mg90HTSA17043-A11/2020
65862-551-90Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg90HTSB17049-A08/2020
65862-551-90Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg90HTSB17054-A10/2020
65862-551-90Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg90HTSB17055-A10/2020
65862-551-90Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg90HTSB17056-A10/2020
65862-551-90Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg90HTSB17057-A10/2020
65862-551-90Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg90HTSB17058-A10/2020
65862-551-90Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg90HTSB17059-A10/2020
65862-551-90Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg90HTSB17060-A10/2020
65862-551-90Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg90HTSB17062-A10/2020
65862-551-90Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg90HTSB17066-A10/2020
65862-551-90Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg90HTSB17067-A11/2020
65862-551-90Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg90HTSB17068-A11/2020
65862-551-90Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg90HTSB17069-A11/2020
65862-551-90Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg90HTSB18001-A12/2020
65862-551-90Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg90HTSB18002-A12/2020
65862-551-90Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg90HTSB18003-A12/2020
65862-551-90Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg90HTSB18004-A12/2020
65862-551-90Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg90HTSB18005-A12/2020
65862-551-90Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg90HTSB18006-A12/2020
65862-551-90Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg90HTSB18007-A12/2020
65862-547-90Valsartan and Hydrochlorothiazide tablets USP 80mg/12.5mg90HVSA17011-A11/2020
65862-547-90Valsartan and Hydrochlorothiazide tablets USP 80mg/12.5mg90HVSA17012-A11/2020
65862-547-90Valsartan and Hydrochlorothiazide tablets USP 80mg/12.5mg90HVSA18001-A12/2020
65862-549-90Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg90HVSB17023-A08/2020
65862-549-90Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg90HVSB17036-A11/2020
65862-549-90Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg90HVSB17037-A11/2020
65862-549-90Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg90HVSB17038-A11/2020
65862-549-90Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg90HVSB17039-A11/2020
65862-549-90Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg90HVSB17040-B11/2020
65862-549-90Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg90HVSB18001-A12/2020
65862-549-90Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg90HVSB18002-A12/2020
65862-549-90Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg90HVSB18003-A12/2020
65862-549-90Valsartan and Hydrochlorothiazide tablets USP 160mg/25mg90HVSB18004-A12/2020
65862-548-90Valsartan and Hydrochlorothiazide Tablets USP 160mg/12.5mg90HTSA17037-A10/2020
65862-548-90Valsartan and Hydrochlorothiazide Tablets USP 160mg/12.5mg90HTSA17039-A10/2020
65862-551-90Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg90HTSB17063-A10/2020
65862-551-90Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg90HTSB17064-A10/2020
65862-551-90Valsartan and Hydrochlorothiazide Tablets USP 320mg/25mg90HTSB17065-A10/2020
65862-551-90Valsartan and Hydrochlorothiazide Tablets USP & 320/25mg90HTSB18029-A03/2021
65862-573-90Valsartan Tablets USP 320mg90VUSD17008-A07/2019
65862-573-90Valsartan Tablets USP 320mg90VUSD17009-A09/2019

 

What to do

Patients who are prescribed the recalled medications, which are used to control high blood pressure and for the treatment of heart failure should continue taking them, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.

Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

The company is notifying customers by phone and in writing with instructions for returning recalled products.

Patients with medical questions regarding this recall or to report an adverse event may contact Aurobindo Pharma USA at (866) 850-2876 (Option 2) or by email at pvg@aurobindousa.com.

Consumers with questions may contact Inmar\CLS-Medturn at (877) 208-2407 9 am -5:00 pm (ET) or by email at rxrecalls@inmar.com.

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