Safety

Company Announcement

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

For Immediate Release

December 31, 2018

Contact

Consumers

Aurobindo Pharma USA
pvg@aurobindousa.com
1-866-850-2876 Option 2

Consumers

Inmar\CLS-Medturn
rxrecalls@inmar.com
1-877-208-2407

Announcement

Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product.   The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.

Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP are indicated to control high blood pressure and for the treatment of heart failure. Patients who prescribed Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP should continue taking their medication, 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 products subject to recall are listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.


NDC
Name and strength Count Lot number Expiry
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

Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP were distributed nationwide to Aurobindo Pharma USA, Inc. wholesale, distributor, repackager and retail customers. Aurobindo Pharma USA, Inc. is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts.  Aurobindo Pharma USA, Inc. is arranging for return of all recalled products to Inmar/CLS Medturn.  Instructions for returning recalled products are given in the recall letter.

Consumers with medical questions regarding this recall or to report an adverse event can contact Aurobindo Pharma USA, Inc. at: 

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Any general questions regarding the return of this product please contact Inmar\CLS-Medturn at 1-877-208-2407 or email rxrecalls@inmar.com (live calls received 9 am -5:00 pm Eastern Time).

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

###

Product Photos

“Valsartan Tablets USP, 320 mg, 90 Tablets”

“Amlodipine and Valsartan Tablets USP, 5 mg/160mg, 30 Tablets”

“Amlodipine and Valsartan Tablets USP, 5 mg/320 mg, 30 Tablets”

"Valsartan and Hydrochlorothiazide Tablets, USP, 160 mg/25 mg, 90 Tablets”

“Amlodipine and Valsartan Tablets USP, 10 mg/320 mg, 30 Tablets”

“Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/12.5 mg, 90 Tablets”

“Valsartan and Hydrochlorothiazide Tablets, USP, 160 mg/12.5 mg, 90 Tablets”

“Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, 90 Tablets”

“Valsartan and Hydrochlorothiazide Tablets, USP, 80 mg/12.5 mg, 90 Tablets”

“Amlodipine and Valsartan Tablets USP, 10 mg/160 mg, 30 Tablets”

Page Last Updated: 12/31/2018
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