WASHINGTON, D.C. — The U.S. Food and Drug Administration will work with drug manufacturing companies to recall generic versions of Zantac because of the presence of a potentially cancer-causing agent located in the medication. The U.S. FDA said that potentially cancer-causing agent in Zantac is n-nitrosodimethylamine or NDMA for short. The active ingredient in Zantac and generic heartburn medications like Zantac is ranitidine. Ranitidine received FDA approval to treat stomach ailments like acid reflux disease, heartburn, sour stomach, and intestinal ulcers in the prescription and non-prescription formulas. Not every medication containing ranitidine received a recall. Curiously Zantac has not been recalled, unlike its generic competitors.
Two ranitidine manufacturers, Apotex and Sandoz, issued recalls of their medications. The companies said they issued recalls because of the concern the FDA expressed over people taking medication tainted by a cancer-causing chemical. One of the manufacturers made ranitidine-based products for pharmaceutical retailers like Rite Aid, Walgreens, and Walmart. The other manufacturer made ranitidine capsules in the generic form.
The FDA will continue testing products with ranitidine produced by various pharmaceutical companies. Additionally, the FDA will persist with its examination of the effects NDMA can have on the body. Health agencies in Europe are also examining the effect of NDMA consumption.
NDMA was discovered in medicines designed to treat heart conditions as well. The FDA learned that losartan medicines were tainted by NDMA, as well. Those medicines treated high blood pressure and other heart ailments.
Sandoz recalled fourteen lots of ranitidine hydrochloride capsules in 150mg and 300mg doses. Before announcing the recall, Sandoz said it would introduce a distribution stop. Drugs subject to a distribution stop can be sold, unlike drugs subject to a recall.
Apotex Corporation announced a recall campaign for its 75mg and 150mg over-the-counter generic Zantac medications. Retail drugs stores Rite Aid, Walmart, and Walgreens pulled their inventory of generic Zantac drugs from their shelves because of this recall.
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