FDA Urged to Expedite Ranitidine Recalls

September 25, 2019

Online pharmacy that discovered the impurity discontinues sales.

Sandoz is voluntarily certain lots of prescription ranitidine (Zantac) because of contamination from a carcinogenic impurity and an online pharmacy is urging the FDA to recall all ranitidine products.

Sandoz initiated a voluntary recall of 14 lots of prescription ranitidine capsules because the carcinogenic impurity N-nitrosodimethylamine (NDMA) was found at higher levels than those approved by the FDA. The lots-most manufactured in 2017-were distributed to wholesalers nationwide.

The situation has quickly escalated over the past week. In mid-September, the FDA acknowledged that NDMA was found in some ranitidine products, but that the levels “are no greater than what would be found in common foods,” the agency said at the time. 

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In the new Sandoz recall announced by the FDA, Acting FDA Commissioner Ned Sharpless, MD, said the agency began testing ranitidine products immediately after learning of the potential impurity. “We will continue to investigate and work to ensure these types of impurities do not exceed acceptable limits, so that patients can continue taking the medicines they need without concern,” Sharpless says.

Online pharmacy Valisure, which it says first discovered the link between ranitidine and NDMA formation during its routine analysis of drug products in its pharmacy, is urging the FDA to “expeditiously request recalls of all ranitidine products to protect the American public from further exposure to the potentially carcinogenic properties of ranitidine,” Valisure said in a Citizens Petition to the FDA.

Valisure found “extremely high levels of NDMA in all lots tested, across multiple manufacturers of ranitidine products and in ranitidine reference standard,” the pharmacy said in its petition.

Valisure tested branded Zantac, as well as generic ranitidine products from Walmart, Walgreens, and CVS.

“Due to its discovery of NDMA, “Valisure’s pharmacy will no longer sell any of the ranitidine products it has acquired, nor does it expect to be able to obtain a refund for these products in light of the fact that ranitidine’s carcinogenicity has not been fully vetted by the FDA,” the company says.

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While the FDA investigates the root cause and risk, consumers and patients can continue to take ranitidine that has not been recalled, the agency says. “It is important to remember that not all ranitidine marketed in the US is being recalled,” the FDA says.

Conversely, consumers taking OTC ranitidine could consider using other OTC products for their condition, the FDA says.

The agency is testing ranitidine products from multiple manufacturers and assessing the possible effect on patients who have been taking ranitidine, as well as what manufacturers can do to reduce or eliminate nitrosamine in drugs.