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Cancer risks prompt FDA to recall more heartburn medication

Audrey Conklin

The Food and Drug Administration announced "numerous" recalls of heartburn and blood pressure medications containing traces of carcinogens, due to potential cancer risks.

Pharmaceutical distributor Denton Pharma Inc., an affiliate of Northwind Pharmaceuticals, on Wednesday announced a recall of antacid medications containing the "probable" carcinogen N-nitrosodimethylamine (NDMA) including Ranitidine Tablets, according to a Wednesday alert from the FDA. Ranitidine is a drug found in Zantac and other heartburn medications.

NDMA is most commonly found in water and foods, including meats, dairy products and vegetables. The FDA has been investigating NDMA since 2018.

The products Denton has recalled are unexpired and are between 150 mg and 300 mg. The 150 mg products are packaged in bottle packs containing units of 24, 30, and 90 tablets, whereas the 300 mg product is packaged in bottle packs containing units of 15 and 90 tablets.

Consumers who have Ranitidine Tablets "subject to this recall should immediately discontinue use, discard remaining product and consult with their physician or healthcare provider about treatment options," the FDA said in the alert.

Appco Pharma also recalled ranitidine packages due to possible traces of NDMA.


Mylan N.V. also announced a recall on Wednesday of three lots of Nizatidine, which is used to treat duodenal ulcers and acid reflux. Trace amounts of NDMA were found in the drug, which was manufactured by Solara Active Pharma Sciences Limited.

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.

The FDA has not received any reports of injury or illness related to these recalls.


FOX Business' James Legate and Matthew McNulty contributed to this report.

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