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

PUBLISHED: Jul 18, 2018
Relevant to: Ambulatory Care, Critical Access Hospitals, Home Health, Hospitals, Long Term Care, Medical Office, Pharmacy, Rural Health Clinics

Teva Pharmaceuticals USA is conforming the 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.

This recall was announced by the US Food and Drug Administration earlier this week, please see StayAlert! Notice published on July 16, 2018 for that announcement.

According to Teva Pharmaceutical’s recall notice, 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.

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.

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.

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