Mylan N.V. announced a recall of three lots of Nizatidine, which is used to treat duodenal ulcers and acid reflux. Trace amounts of NDMN-(N- nitrosodimethylamine) found in the drug, which was manufactured by Solara Active Pharma Sciences Limited.
Nizatidine is indicated for the short-term treatment (up to 8 weeks) of active duodenal ulcers and active benign gastric ulcers, as maintenance therapy for duodenal ulcer patients for up to one year, and for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD).
NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. NDMA has been classified as a probable human carcinogen (a substance that could cause cancer) according to the International Agency for Research on Cancer (IARC).
The recalled medications include 60-count bottles of 150mg Nizatidine Capsules, USP expiring in May of 2020 with lot number 3086746; 30-count bottles of 300mg Nizatidine Capsules, USP expiring in January of 2020 with lot number 3082876; and 30-count bottles of 300mg Nizatidine Capsules, USP expiring in January of 2020 with lot number 3082877, according to Mylan.
The FDA released the results of preliminary tests of safer, carcinogen-free antacid alternatives, including the likes of Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole), all of which were found to have no traces of the potentially cancer-causing agent NDMA.
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