Teva Pharmaceuticals is recalling all lots of combination tablets featuring the drugs amlodipine and valsartan and another combination drug featuring amlodipine, valsartan, and hydrochlorothiazide due to an impurity detected.
The impurity is N-nitroso-diethylamine or NDEA, which has been classified as a probable human carcinogen, according to the U.S. Food and Drug Administration.
The combination tablets are used for treating high blood pressure. Teva hasn’t received any reports of adverse events signaling a potential link or exposure to valsartan, according to a statement from Teva posted by the FDA.
Patients taking the combination tablets are advised to continue taking their medication and to contact their pharmacist or physician for advice on alternative treatment. The risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any comparable alternative treatment, Teva said.
Customers and patients with questions can call 888-838-2872 or email druginfo@tevapharm.com.
The FDA announced an expanded recall of valsartan in August because products could contain the impurity. Two more recalls were announced in October – one for irbesartan and another for losartan potassium hydrochlorothiazide tablets.
Adverse reactions or other problems experienced with the use of the products can be reported to Teva at 888-838-2872 or to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax:
- Complete and submit the report online: fda.gov/medwatch/report.htm.
- Regular mail or fax: Download form fda.gov/MedWatch/getforms.htm or call 800-332-1088 to request a form, then complete and return to the address on the pre-addressed form, or submit by fax to 800-FDA-0178.
