Three major pharmacy chains elected earlier this week to remove the antacid ranitidine from their shelves. CVS, Walgreens, and Rite Aid have pulled branded Zantac and all generic formulations of the drug in a cautionary move related to an FDA alert in mid-September that a number of lots of the drug had been contaminated.
On Wednesday, October 2, a follow-up FDA communication said that the agency’s “early limited testing” of ranitidine samples found low but “unacceptable” levels of the suspected human carcinogen nitrosodimethylamine (NDMA).
FDA, explaining that a third-party laboratory’s recent testing of the drug used a high-temperature method that generates very high levels of NDMA from ranitidine, asked manufacturers of ranitidine in its October 2 update to “conduct their own laboratory testing to determine levels of NDMA in their products” and to follow guidelines for a test the agency has created that does not use “elevated temperatures.”
Actual levels of NDMA have not yet been confirmed and FDA has not publicly sought product recalls.
For its part, CVS said in a statement about removing ranitidine products: “This action is being taken out of an abundance of caution due to a recent Product Alert from the U.S. Food and Drug Administration (FDA) that ranitidine products may contain a low level of nitrosodimethylamine (NDMA), which is a probable human carcinogen.”
CVS made its decision to suspend branded and generic ranitidine sales on Saturday, September 28, and was followed by Rite Aid and Walgreens on Monday, September 30, 2019. All three retailers have announced that customers may return ranitidine medications for a full refund.
FDA on September 13 first issued a statement warning that some lots of ranitidine were found to contain NDMA, classified as a probable human carcinogen. NDMA, part of the nitrosamine chemical family, is also a “known environmental contaminant” and last year was found in popular angiotensin receptor blockers used to treat hypertension.
September 24, 2019 FDA announces voluntary recall of Sandoz ranitidine capsules following detection of an impurity
September 26, 2019 FDA alerts health care professionals and patients to voluntary recall of ranitidine medicines
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