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.
The 29 lots of single and 51 lots of combination Valsartan medicines distributed under the Actavis label in the U.S. are being recalled 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.
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.
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.
The products subject to recall can be seen below:
| 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 |
Source: United States Food & Drug Administration
