Elevated Levels of NDMA Lead to Appco Pharma Ranitidine Recall

Published on January 8, 2020 by Sandy Liebhard

Appco Pharma has become the latest drug maker to announce a ranitidine recall, after elevated levels of a potentially cancer-causing chemical were detected in the company’s generic version of Zantac.

What’s Included in the Appco Ranitidine Recall?

The recall affects all quantities and lots of Appco’s Ranitidine Hydrochloride Capsules, 150 mg and 300 mg, within expiry. The recalled drugs can be identified by checking the product name, count/bottle, manufacturer details and batch or lot number on the bottle containing these medications. A list of the affected ranitidine products is available at the U.S. Food & Drug Administration’s (FDA) website.

“Ranitidine Hydrochloride Capsules are being recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake levels established by the FDA, based on FDA-validated tests,” the recall notice states. “To date, Appco has not received any reports of adverse events related to use of the product as part of this recall.”

The 150 mg and 300 mg doses of Zantac and ranitidine are only available via prescription and are indicated to treat onditions associated with the excess production of stomach acid, including duodenal ulcer, benign gastric ulcer, reflux esophagitis, post-operative peptic ulcer, and Zollinger-Ellison Syndrome. Lower doses of the drugs are available over-the-counter to relieve symptoms associated with heartburn.

Ranitidine and NDMA

In September, the FDA warned 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 chemical in every sample it tested, and frequently at levels that far exceeded the FDA’s recommended daily amount of 96 nanograms.

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.

Valisure believes the elevated presence of NDMA resulted from the instability of the ranitidine molecule, which purportedly degrades under conditions similar to human digestion. Just last week, California-based Emery Pharma said its own testing 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.

Status of Zantac and Ranitidine Recalls

Both Valisure and Emery have petitioned the FDA to order a Zantac and ranitidine recall, but so far, the agency has declined to do so. While its own ranitidine and  Zantac testing has detected NDMA at levels ranging from safe to unacceptable, the FDA is still working to detrxinjuryhelp.com/zantac/lawsuit/ermine if the chemical forms in the human stomach after ingestion.

A growing number of drug makers have opted to announce voluntary recalls, while various retailers, including CVS, Rite-Aid, Walmart and Walgreens, have removed Zantac and ranitidine products from their store shelves.

For now, the FDA is only advising consumers who take over-the-counter versions of  Zantac and ranitidine to consider switching to an alternative heartburn medication. Those taking prescription versions should not stop treatment without first talking with their doctor, as doing so could cause their condition to worsen.