Sanofi has followed several generic manufacturers of ranitidine products in issuing a voluntary recall as a result of N-nitrosodimethylamine (NDMA) contamination. The affected products include Zantac 150, Zantac 150 Cool Mint, and Zantac 75. Ranitidine, a histamine-2 blocker, reduces the production of stomach acid and the OTC tablets are marketed to relieve heartburn resulting from acid indigestion.
NDMA is classified as a probable human carcinogen and is a known environmental contaminant found in water and a variety of foods.
In mid-September, the FDA announced that it had found NDMA in ranitidine products including Zantac and generics, but the agency did not recommend a recall of the products given the low amounts of the contaminant that had been found at the time.
Since then, the FDA has announced multiple voluntary recalls. On September 24, Sandoz issued the first, voluntarily recalling 14 lots of its prescription version of ranitidine. Since then, the recalls have included ranitidine products made by Apotex Corporation and generics marketed under the Walgreens, Walmart, and Rite Aid labels; Lannett Company’s ranitidine syrup; Novitium’s ranitidine capsules; and Perrigo’s OTC tablets. Dr. Reddy’s Laboratory recalled all prescription and OTC ranitidine tablets and capsules, which were sold under the Walgreens, Walmart, CVS, Target, and Kroger labels.
On November 1, the FDA issued a statement that said that it had “found levels of NDMA in ranitidine that are similar to levels you would expect to be exposed to if you ate common foods like grilled or smoked meats,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research noted that while the levels found in FDA testing proved to be “much lower than the levels some third-party scientists first claimed, some levels still exceed what the FDA considers acceptable for these medicines.”
The FDA asked manufacturers to voluntarily recall ranitidine products if FDA testing or their own laboratory results show higher than acceptable limits of NDMA, 96 nanograms per day, or 0.32 ppm. The agency also announced that it had found higher-than-acceptable levels of NDMA in some lots of ranitidine syrup, used in infants and children, which has led to recalls. Testing of injectable ranitidine is continuing.
In a chart summarizing testing results to date, NDMA levels ranged from well within acceptable limits to nine times the maximum.
Products that had lots that exceeded the maximum level in FDA testing included Sanofi’s 150-mg and 75-mg OTC tablets and 150-mg prescription tablets, Cardinal Health’s 150-mg tablets, Novitium’s 300-mg capsules, Dr. Reddy’s 300-mg tablets, Sandoz’s 300-mg product, Aurobindo’s 300-mg tablets, Silarx Pharma’s 150-mg syrup, and Amneal Pharmaceuticals’ 300-mg syrup.
In addition, the FDA asked manufacturers to expand their testing to include nizatidine or Axid, as it is chemically similar to ranitidine, and to send samples for testing to the FDA.
Pharmacists can help patients who take ranitidine to better understand their options. The FDA has not found NDMA in other drugs in the histamine-2 blocker or proton-pump inhibitor classes, so Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), or Prilosec (omeprazole) may all be recommended.
« Click here to return to OTC Update.