- Contact Us
- News and Events
- Investor Relations
- Locations and Facilities
- Careers
- About Our Site
- Accessibility Statement
- Privacy Policy
- Terms and Conditions
- For Employers and Medical Plan Providers
- For Pharmacists and Medical Professionals
- Drug Lists
- Drug Safety Alerts
- Emergency Response
- Mail Service Numbers, Forms and Information
- Specialty Pharmacy Services, Information and Forms
- Electronic Prior Authorization Information
- Clinical Drug Information
- Clinical Programs and Health Management
- Clinical Publications
- FAQs For Pharmacists and Pharmacy Staff
- Pharmacy Help Desk
- FAQs For Prescribers and Office Staff
- Contact Us | Health Professionals Only
Drug Safety Alerts
Teva Valsartan Combination Products Consumer-Level Recall
11/26/18
On November 26, 2018, Teva Pharmaceuticals issued a consumer-level recall of all lots of amlodipine/valsartan combination tablets and amlodipine/valsartan/hydrochlorothiazide combination tablets. This recall was issued due to an impurity, N-nitrosodiethylamine (NDEA), which is above specification limits in the Valsartan Active Pharmaceutical Ingredient (API) that was manufactured by Mylan Laboratories Limited in India. NDEA 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 according to the International Agency for Research on Cancer (IARC).
A complete list of the affected products is provided here:
Valsartan is used for the treatment of high blood pressure for the treatment of heart failure, and to reduce cardiovascular mortality following myocardial infarction. Valsartan in combination with amlodipine or hydrochlorothiazide is used for the treatment of high blood pressure. 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 the patient's health may be higher if the treatment is stopped immediately without any alternative treatment.
CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking product affected by this recall to contact their prescriber.
For more information about this recall, health care providers may contact Teva Medical Information at 1-888-838-2872, Monday through Friday, 9:00 am to 5:00 pm (ET) and select option 3 then option 4 or visit http://phx.corporate-ir.net.
You may also contact the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.