FDA: 2 companies voluntarily recall more heartburn medications

Photo: (U.S. Air Force photo/Airman 1st Class Andrea Posey)

Jan. 12 (UPI) — Pharmacies have pulled generic versions of heartburn drug Zantac from shelves after federal officials disclosed two voluntary recalls this week over NDMA, a probable human carcinogen in the drug.

Ranitidine, known by the brand name Zantac, is a histamine-2 blocker that decreases the amount of acid in the stomach to treat and prevent stomach ulcers and gastroesophageal reflux disease also known as GERD.

Earlier this week Appco Pharma LLC announced a voluntary recall of prescription 50 mg and 300 mg ranitidine tablets.

Denton Pharma, doing business as Northwind Pharmaceuticals, announced a voluntary recall earlier this week of 150 mg and 300 mg prescription ranitidine tablets, manufactured by Glenmark Pharmaceutical, according to the U.S. Food and Drug Administration update.

Neither company reported any adverse events directly related to the recall, but nevertheless advised consumers to immediately discontinue use, discard the product and consult physician for other treatment options.

Both companies recalled the drugs over risk of NDMA presence, which has prompted a series of recalls of heartburn drugs over recent months, and similarly led to recall of several versions of blood-pressure lowering pills.

NDMA is an environmental contaminant found in water and foods, including meats, dairy products and vegetables and is classified as a probable human carcinogen.

Additionally, Mylan global announced earlier this week that its U.S.-based pharmaceutical business conducted a voluntary recall of three lots of 150 mg and 300 mg nizatidine capsules, which are known by the brand name Axid, and provide short-term treatment of ulcers and GERD, similarly over NDMA.


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