The products contain a trace amount of an unexpected impurity
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of ConsumerAffairs
July 18, 2018Clik here to view.
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Teva Pharmaceuticals USA is recalling 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label, which are used for the treatment of hypertension (high blood pressure) and heart failure.
Trace amounts of an unexpected impurity -- N- nitrosodimethylamine (NDMA -- were found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical.
NDMA has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.
Teva says it has not received any reports of adverse events related to this recall.
The following products, packed in bottles and distributed nationwide, are being recalled:
| 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 |
| 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 |
| 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 |
| 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 |
What to do
Consumers with questions about the recall may contact Teva at (888) 838-2872, option 3, Monday Friday, 9:00AM 5:00PM (ET) or by email at druginfo@tevapharm.com.