Nearly two weeks after a probable carcinogen was discovered at low levels in heartburn medications, the unused medications are recalled.
Pharmaceutical manufacturer Apotex said on Thursday it voluntarily remembers 75 mg and 150 mg of ranitidine tablets sold at Walgreens, Walmart and Rite Aid over the possible presence of carcinogenic impurities NDMA.
USA Today notes that the acid-reducing drugs are generic versions of Zantac. The FDA has the complete list of recalled products here. Earlier this week, Novartis-owned Sandoz recalled 30-count, 50-count and 500-count bottles of prescription ranitidine capsules, and overseas, British drug maker GlaxoSmithKline recalls 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 the sale of drugs containing ranitidine, reports ABC News.
The FDA is testing Zantac and its generic versions, but has so far not asked drug makers for a recall. And Sanofi, which manufactures the brand name Zantac, is yet to make any effort.
"The FDA reported that levels of N-nitrosodimethylamine (NDMA) in ranitidine in preliminary tests hardly exceed amounts found in regular foods," said a spokesman for Sanofi. "We work closely with the FDA and conduct our own robust investigations to ensure that we continue to meet the highest safety and quality standards."
NDMA and two other carcinogens have also led to extensive recalls of blood pressure and heart medication since last year. Production errors were blamed for that, but in this case, experts say that enzymes in a person's body are likely to react with the ranitidine molecule and actually produce NDMA. See the FDA's updates here. (Read more about drug recall.)
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