Teva Recalls All Amlodipine/Valsartan Combination Products in US

Megan Brooks

November 27, 2018

Teva Pharmaceuticals has recalled all lots of amlodipine/valsartan combination tablets and amlodipine/valsartan/hydrochlorothiazide combination tablets in the United States after N-nitroso-diethylamine (NDEA) was detected in an active pharmaceutical ingredient (API) manufactured by Mylan India.

NDEA is a probable human carcinogen. The Teva recall, announced November 27, marks the latest recall of tainted sartan products in the United States.

To date, Teva has not received any reports of adverse events related to this recall, the company said.

Detailed information on the recalled product, including lot numbers, expiration dates, strengths, bottle size, and national drug codes are available on the US Food and Drug Administration (FDA) website.

Teva Pharmaceuticals USA is notifying its distributors and customers by certified mail and is arranging for return/reimbursement of returned recalled products. Distributors and retailers that have product that is being recalled should immediately stop distribution and quarantine any quantities remaining in their control and return the recalled product.

Providers and patients with questions about this recall are advised to contact Teva's Medical Information by phone at 888-838-2872, option 3, then option 4, or by email at druginfo@tevapharm.com.

On November 20, as reported by theheart.org | Medscape Cardiology, Mylan Pharmaceuticals announced a recall of 15 lots of medicines containing valsartan because of the presence of the NDEA.

The FDA is continuing to investigate the presence of NDEA and another probable carcinogen, N-nitrosodimethylamine, in angiotensin II receptor blockers and has pledged to take "swift action" when it identifies unacceptable impurities in API and finished drug products.

Adverse reactions or quality problems associated with the use of sartan products should be reported to the FDA's MedWatch Adverse Event Reporting Program.

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