The Food and Drug Administration has recalled several more heartburn medicinal products, including more generic versions of Zantac, found to contain trace amounts of a substance that may be related to cancer.
This substance, N-Nitrosodimethylamine (NDMA), has been classified by the World Health Organization as a “probable human carcinogen.”
The FDA said the presence of NDMA caused Denton Pharma Inc. to recall several batches of unexpired ranitidine tablets. The generic version of the popular Zantac heartburn drug is ranitidine.
The lots of ranitidine tablets are recalled in 150 mg and 300 mg strengths.
Appco Pharma also recalled ranitidine batches due to NDMA potential. The lots recalled are dated April or May 2021. None of the lots recalled was associated with injuries or adverse events.
Mylan Initiates Voluntary Nationwide Recall of 3 Lots of Nizatidine Capsules, USP, Due to Trace Amounts of NDMA (N-Nitrosodimethylamine) Impurity Found in the Active Pharmaceutical Ingredient Manufactured by Solara Active Pharma Sciences Limited https://t.co/pSd3xmViUT pic.twitter.com/1z5hO7rL3f
— U.S. FDA (@FDArecalls) January 9, 2020
On Wednesday, the FDA also announced that the pharmaceutical company Mylan had recalled three batches of a second antiacid, nizatidine. Solara Active Pharma Sciences Limited manufactured such capsules with strengths of 150 mg and 300 mg.
Nizatidine is used to short-term treatment of stomach ulcers and gastroesophageal reflux disease heartburn, written by the FDA on its website.
Recalled bats include the nizatidine capsules packaged in 60 bottles with May expiration date and those sold in 30 bottles with the January expiration date.
The FDA has no records of accidents associated with the use of medicines. It is not clear if such trace amounts of the carcinogens would be toxic if taken as directed. FDA ranitidine test found NDMA levels similar to those in grilled and smoked meats.
Federal regulatory authorities confirmed that no apparent signs of NDMA were found for other heartburn therapeutic medicines such as famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) and omeprazole’s (Prilosec).