Three pharmaceutical companies are recalling antacid medications due to concerns that the drugs might be contaminated with a potentially cancer-causing impurity called N-Nitrosodimethylamine, or NDMA.
According to the U.S. Food & Drug Administration (FDA), two of the companies — Denton Pharma Inc. and Appco Pharma LLC – are recalling multiple batches of ranitidine tablets and ranitidine hydrochloride. Ranitidine is the generic form of Zantac, one of the most popular antacids on the market.
Denton Pharma’s recall involves all unexpired lots of 150 mg and 300 mg tablets distributed to Northwind Pharmaceuticals LLC and Crosswind Pharmacy. These prescription strength products can be identified by the NDC number on the product label.
Appco Pharma also recalled 150 mg and 300 mg batches of its ranitidine hydrochloride capsules. NDC numbers for the affected drugs can be found here.
Finally, Mylan Pharmaceutical recalled three Lots of nizatidine capsules, USP, — also known as Axid — after trace amounts of NDMA were found in active pharmaceutical ingredient manufactured by Solara Active Pharma Sciences Limited. Identifying information for these products can be found here.
So far, the medications involved in these three recalls have not been linked to any adverse events.
NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Because of laboratory tests linking it to certain cancers, especially tumors of the liver, kidneys, and gastrointestinal tract, NDMA is designated a probable human carcinogen.
Last September, the FDA notified consumers that elevated levels of NDMA had been detected in some samples of ranitidine and Zantac. The agency was informed of the issue by Valisure, an online pharmacy that said it detected the probable carcinogen in every sample it tested, and frequently at levels that far exceeded the FDA’s recommended daily amount of 96 nanograms.
Valisure maintains that NDMA in Zantac and ranitidine resulted from the instability of the ranitidine molecule, which purportedly degrades under conditions similar to human digestion. California-based Emery Pharma later suggested ranitidine produced unacceptably high levels of NDMA when exposed to heat for as little as five days, even after the drug has been packaged, indicating the carcinogen might form during storage and shipment.
While its own tested detected NDMA at levels ranging from safe to unacceptable, the FDA is still working to determine the source of the contamination.
In the meantime, a growing number of plaintiffs have filed Zantac lawsuits alleging tainted medications were responsible for the development of cancer. Last year, several requested that the U.S. Judicial Panel on Multidistrict Litigation allow all such federal claims in a single jurisdiction. The Panel will hear oral arguments on the matter later this month.