Another pharmaceutical company has recalled a heartburn drug because it may contain a human carcinogen known as NDMA.
Bridgewater, New Jersey-based Amneal Pharmaceuticals, LLC, is recalling ranitidine tablets and syrup “because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA,” according to the U.S. Food and Drug Administration.
Ranitidine is an antacid and antihistamine used to treat gastrointestinal disorders.
According to the FDA, NDMA “is classified as a probably human carcinogen (a substance that could cause cancer) based on results of laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.”
Earlier this year, the brand name Zantac was pulled from shelves at CVS as well as the CVS brand because both contain ranitidines.
Other pharmaceutical companies have already recalled ranitidine. Previously, blood pressure and heart medications that contain ranitidines were recalled, including Valsartan, Losartan and Irbesartan.
The ranitidine tablets in the recall are 150 mg and 300 mg as well as ranitidine syrup, 15mg/mL.
For a complete list of the medication recalled and NDC numbers, lot numbers and expiration dates associated with them, click here.
According to the FDA, Amneal is notifying its customers by mail.
Customers who purchased the product directly from Amneal should call Stericycle at 866-918-8768, 8 a.m. to 5 p.m. weekdays.
People who have had adverse reactions to taking the drug, can contact Amneal Drug Safety at 1-877-835-5472, 8 a.m. to 6 p.m. weekdays or by sending an email to email@example.com.
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