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FDA: Acid Reflux Drug Recalled Due to Possible Human Carcinogens

By rlsmetro on
New Jersey

Denton Pharma, Inc. dba Northwind Pharmaceuticals, an affiliate of Northwind Pharmaceuticals, LLC (“Northwind”) today announced the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300mg, to the consumer level.

The recall is in response to the manufacturer’s recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300 mg, which were repackaged by Denton Pharma, Inc. dba Northwind Pharmaceuticals.

To date, Northwind has not received any reports of adverse events that have been confirmed to be directly related to this recall.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

NDMA is a known environmental contaminant typically found in water and foods, including meats, dairy products and vegetables.

The Ranitidine Tablets, USP, distributed by Northwind are prescription oral products. Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach.

Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.