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.

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).

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.