Posted from: Tuesday, December 11, 2018 - 05:18 PM - Present

Teva Issues Nationwide Recall of All Amlodipine/Valsartan and Amlodipine/Valsartan/Hydrochlorothiazide Tablets within Expiry

November 27, 2018 – Teva Pharmaceuticals has voluntarily recalled all lots of its Amlodipine/Valsartan and Amlodipine/Valsartan/Hydrochlorothiazide combination tablets within expiry due to an impurity detected in the valsartan active pharmaceutical ingredient (API).

Like a number of other angiotensin receptor II blocker (ARB) products recalled through the latter half of 2018, Teva’s recalled amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide tablets contain a “sartan” API contaminated with a probable carcinogen (cancer-causing agent). In this instance, that API is valsartan manufactured at a Mylan plant in India. The impurity is N-nitrosodiethylamine (NDEA), which occurs in small amounts in certain foods, drinking water, air pollution, and industrial processes.

Patients taking the recalled medication should not stop without first consulting a doctor or pharmacist, as doing so could have serious health risks.

Patients who wish to contact Teva with medical-related questions, questions about the recalled products, or reports of an adverse event can call 888-838-2872 (select option 3, then option 4). Teva can also be reached by email at druginfo@tevapharm.com. In addition, adverse events can be reported to the FDA through its MedWatch program.

Further information regarding the recall can be found at:

Benecard Central Fill, BeneCard PBF’s mail order pharmacy, does not currently dispense the recalled items, and is notifying a small number of members who may have received the recalled Teva products in 2017 or the first half of 2018.

Last Updated Monday, September 16, 2019 - 08:53 AM.