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Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N-nitrosodimethylamine (NDMA), 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, TEVA has not received any reports of adverse events related to this recall.

Valsartan is used for the treatment of hypertension (high blood pressure) and for the treatment of heart failure. It is also indicated as a treatment for left ventricular failure and left ventricular dysfunction following myocardial infarction. In combination with hydrochlorothiazide, it is used in the treatment of hypertension.

Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on valsartan should continue taking their medication, as the risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.

The products subject to recall and listed below are packed in bottles. These lots were distributed Nationwide to Teva’s Direct Accounts (Wholesale/Distributor/Retail/Repackagers/VA Pharmacy, et. al).

                   
NDC     Product Description/Strength/Bottle Size     Lot     Expiration
0591-2167-19     Valsartan 40MG Tablets, USP 90 Count     1196934M     Sep-2018
0591-2167-19     Valsartan 40MG Tablets, USP 90 Count     1238462M     May-2019
0591-2167-19     Valsartan 40MG Tablets, USP 90 Count     1268429A     Oct-2019
                   
0591-2167-30     Valsartan 40MG Tablets, USP 30 Count     1196936A     Sep-2018
0591-2167-30     Valsartan 40MG Tablets, USP 30 Count     1238463A     May-2019
0591-2167-30     Valsartan 40MG Tablets, USP 30 Count     1270617A     Oct-2019
                   
0591-2168-10     Valsartan 80MG Tablets, USP 1000 Count     1177114A     Jul-2018
0591-2168-10     Valsartan 80MG Tablets, USP 1000 Count     1219360M     Feb-2019
0591-2168-10     Valsartan 80MG Tablets, USP 1000 Count     1250706A     May-2019
           
                   
NDC     Product Description/Strength/Bottle Size     Lot     Expiration
0591-2168-19     Valsartan 80MG Tablets, USP 90 Count     1175947M     Jul-2018
0591-2168-19     Valsartan 80MG Tablets, USP 90 Count     1175948M     Jul-2018
0591-2168-19     Valsartan 80MG Tablets, USP 90 Count     1177115A     Jul-2018
0591-2168-19     Valsartan 80MG Tablets, USP 90 Count     1219361A     Feb-2019
0591-2168-19     Valsartan 80MG Tablets, USP 90 Count     1240434M     May-2019
0591-2168-19     Valsartan 80MG Tablets, USP 90 Count     1250704M     May-2019
                   
0591-2169-10     Valsartan 160MG Tablets, USP 1000 Count     1175922M     Jul-2018
0591-2169-10     Valsartan 160MG Tablets, USP 1000 Count     1220826M     Feb-2019
0591-2169-10     Valsartan 160MG Tablets, USP 1000 Count     1236294M     May-2019
0591-2169-10     Valsartan 160MG Tablets, USP 1000 Count     1240427M     May-2019
0591-2169-10     Valsartan 160MG Tablets, USP 1000 Count     1270616A     Aug-2019
                   
0591-2169-19     Valsartan 160MG Tablets, USP 90 Count     1177880A     Jul-2018
0591-2169-19     Valsartan 160MG Tablets, USP 90 Count     1220831A     Feb-2019
0591-2169-19     Valsartan 160MG Tablets, USP 90 Count     1263941A     Aug-2019
                   
0591-2170-05     Valsartan 320MG Tablets, USP 500 Count     1208000M     Oct-2018
0591-2170-05     Valsartan 320MG Tablets, USP 500 Count     1208001M     Oct-2018
0591-2170-05     Valsartan 320MG Tablets, USP 500 Count     1240425A     Jun-2019
                   
0591-2170-19     Valsartan 320MG Tablets, USP 90 Count     1208002A     Oct-2018
0591-2170-19     Valsartan 320MG Tablets, USP 90 Count     1247282M     May-2019
0591-2170-19     Valsartan 320MG Tablets, USP 90 Count     1263944M     Aug-2019
           
                   
NDC     Product Description/Strength/Bottle Size     Lot     Expiration
0591-2315-19     Valsartan and Hydrochlorothiazide 80/12.5MG Tablets, USP 90 Count     1191191M     Aug-2018
0591-2315-19     Valsartan and Hydrochlorothiazide 80/12.5MG Tablets, USP 90 Count     1191192M     Aug-2018
0591-2315-19     Valsartan and Hydrochlorothiazide 80/12.5MG Tablets, USP 90 Count     1191193M     Aug-2018
0591-2315-19     Valsartan and Hydrochlorothiazide 80/12.5MG Tablets, USP 90 Count     1191194M     Aug-2018
0591-2315-19     Valsartan and Hydrochlorothiazide 80/12.5MG Tablets, USP 90 Count     1191195M     Aug-2018
0591-2315-19     Valsartan and Hydrochlorothiazide 80/12.5MG Tablets, USP 90 Count     1238466M     Jun-2019
0591-2315-19     Valsartan and Hydrochlorothiazide 80/12.5MG Tablets, USP 90 Count     1238467M     Jun-2019
0591-2315-19     Valsartan and Hydrochlorothiazide 80/12.5MG Tablets, USP 90 Count     1253261M     Jul-2019
0591-2315-19     Valsartan and Hydrochlorothiazide 80/12.5MG Tablets, USP 90 Count     1256125M     Jul-2019
0591-2315-19     Valsartan and Hydrochlorothiazide 80/12.5MG Tablets, USP 90 Count     1277709M     Sep-2019
                   
0591-2316-19     Valsartan and Hydrochlorothiazide 160/12.5MG Tablets, USP 90 Count     1191160M     Sep-2018
0591-2316-19     Valsartan and Hydrochlorothiazide 160/12.5MG Tablets, USP 90 Count     1191161M     Sep-2018
0591-2316-19     Valsartan and Hydrochlorothiazide 160/12.5MG Tablets, USP 90 Count     1191162A     Sep-2018
0591-2316-19     Valsartan and Hydrochlorothiazide 160/12.5MG Tablets, USP 90 Count     1219363M     Feb-2019
0591-2316-19     Valsartan and Hydrochlorothiazide 160/12.5MG Tablets, USP 90 Count     1219364M     Feb-2019
0591-2316-19     Valsartan and Hydrochlorothiazide 160/12.5MG Tablets, USP 90 Count     1219365A     Feb-2019
0591-2316-19     Valsartan and Hydrochlorothiazide 160/12.5MG Tablets, USP 90 Count     1225613A     Feb-2019
0591-2316-19     Valsartan and Hydrochlorothiazide 160/12.5MG Tablets, USP 90 Count     1233944M     Apr-2019
0591-2316-19     Valsartan and Hydrochlorothiazide 160/12.5MG Tablets, USP 90 Count     1233945M     Apr-2019
0591-2316-19     Valsartan and Hydrochlorothiazide 160/12.5MG Tablets, USP 90 Count     1253253M     Jul-2019
0591-2316-19     Valsartan and Hydrochlorothiazide 160/12.5MG Tablets, USP 90 Count     1253254M     Jul-2019
           
                   
NDC     Product Description/Strength/Bottle Size     Lot     Expiration
0591-2317-19     Valsartan and Hydrochlorothiazide 160/25MG Tablets, USP 90 Count     1191164M     Sep-2018
0591-2317-19     Valsartan and Hydrochlorothiazide 160/25MG Tablets, USP 90 Count     1191165M     Sep-2018
0591-2317-19     Valsartan and Hydrochlorothiazide 160/25MG Tablets, USP 90 Count     1191166M     Sep-2018
0591-2317-19     Valsartan and Hydrochlorothiazide 160/25MG Tablets, USP 90 Count     1191167A     Oct-2018
0591-2317-19     Valsartan and Hydrochlorothiazide 160/25MG Tablets, USP 90 Count     1225612M     Feb-2019
0591-2317-19     Valsartan and Hydrochlorothiazide 160/25MG Tablets, USP 90 Count     1250717M     Jul-2019
0591-2317-19     Valsartan and Hydrochlorothiazide 160/25MG Tablets, USP 90 Count     1256111M     Jul-2019
0591-2317-19     Valsartan and Hydrochlorothiazide 160/25MG Tablets, USP 90 Count     1288798M     Oct-2019
                   
0591-2318-19     Valsartan and Hydrochlorothiazide 320/12.5MG Tablets, USP 90 Count     1191185M     Sep-2018
0591-2318-19     Valsartan and Hydrochlorothiazide 320/12.5MG Tablets, USP 90 Count     1191186M     Sep-2018
0591-2318-19     Valsartan and Hydrochlorothiazide 320/12.5MG Tablets, USP 90 Count     1225615M     Feb-2019
0591-2318-19     Valsartan and Hydrochlorothiazide 320/12.5MG Tablets, USP 90 Count     1233948M     Feb-2019
0591-2318-19     Valsartan and Hydrochlorothiazide 320/12.5MG Tablets, USP 90 Count     1250718M     Aug-2019
0591-2318-19     Valsartan and Hydrochlorothiazide 320/12.5MG Tablets, USP 90 Count     1253257M     Jul-2019
                   
0591-2319-19     Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count     1191188M     Sep-2018
0591-2319-19     Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count     1191189M     Sep-2018
0591-2319-19     Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count     1191190M     Sep-2018
0591-2319-19     Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count     1199220M     Aug-2018
0591-2319-19     Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count     1217576M     Jan-2019
0591-2319-19     Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count     1217577M     Jan-2019
0591-2319-19     Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count     1217578M     Jan-2019
0591-2319-19     Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count     1220832M     Jan-2019
0591-2319-19     Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count     1220833M     Feb-2019
0591-2319-19     Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count     1247283M     Jun-2019
0591-2319-19     Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count     1247284M     Jun-2019
0591-2319-19     Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count     1247285M     Jun-2019
0591-2319-19     Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count     1247286M     Jun-2019
0591-2319-19     Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count     1247287A     Jun-2019
0591-2319-19     Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count     1280632M     Oct-2019
0591-2319-19     Valsartan and Hydrochlorothiazide 320/25MG Tablets, USP 90 Count     1280633M     Oct-2019
           

Teva is notifying its Direct Accounts by FedEx Overnight mailing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts of this product recall and making arrangements for impacted product to be returned to Inmar. Instructions for returning recalled products and crediting are given in the recall letter.

Customers and patients with Medical-related Questions, information about an Adverse Event or other questions about the Teva product’s being recalled should contact Teva’s Medical Information by phone at: 888-838-2872, option 3, then, option 4. Live calls are received Monday-Friday, 9:00AM-5:00PM Eastern Time with Voicemail available 24 hours/day, 7 days/week or email druginfo@tevapharm.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to Teva directly at 888-838-2872 or to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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

Teva Pharmaceuticals USA
Elizabeth DeLuca, 267-468-4329
Elizabeth.DeLuca@tevapharm.com
or
Kelley Dougherty, +1-973-658-0237
Kelley.Dougherty@tevapharm.com