WASHINGTON, D.C. (KETK) – Drugmakers are recalling generic versions of the popular over-the-counter heartburn medication Zantac over concerns that the drug contains low levels of a probable cancer-causing agent.
The OTC drug, ranitidine, is manufactured by Apotex Corp. and sold in Walgreens, Walmart and Rite-Aid pharmacies.
Apotex said it’s recalling 75 mg and 150 mg ranitidine tablets sold over the counter at the three chain pharmacies because the drugs might contain low levels of the cancer-causing impurity NDMA.
Earlier this week, Novartis-owned Sandoz recalled 30-count, 50-count and 500-count bottles of prescription ranitidine capsules, and overseas, British drugmaker GlaxoSmithKline is recalling ranitidine products in India and Hong Kong (it does not sell versions of the drug in the US). Several countries are taking steps to restrict sales of drugs containing ranitidine
The FDA says NDMA (N-nitrosodimethylamine) is classified as a probable human carcinogen, or substance that could cause cancer, based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.
This recall follows a recent FDA statement about NDMA impurities detected in ranitidine medicines. The agency also recently alerted patients and health care professionals of Sandoz Inc.’s voluntary recall of prescription ranitidine hydrochloride capsules due to an NDMA impurity on September 23.
The FDA is testing Zantac and its generic versions, but has not yet asked drugmakers for a recall. And Sanofi, which produces the brand-name Zantac, is not yet making any moves.
“The FDA reported that the levels of N-nitrosodimethylamine (NDMA) in ranitidine in preliminary tests barely exceed amounts found in common foods,” said a Sanofi spokesperson. “We are working closely with the FDA and are conducting our own robust investigations to ensure we continue to meet the highest quality safety and quality standards. At Sanofi, we remain committed to being transparent with our patients and consumers and will share an update when one is available.”
You can find a list of recalled products here.