Recall Expands to Another Hypertension and Heart Failure Drug – Actavis Tablets

Teva Pharmaceuticals USA 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..

This recall is 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.

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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
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

 

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. 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 Monday-Friday, 9:00AM-5:00PM Eastern Time with Voicemail available 24 hours/day, 7 days/week or email [email protected]

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.

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