Generic Zantac Recall Issued By Sandoz Over Potential Cancer Side Effects

Amid concerns about the potential risk of cancer linked to Zantac, Sandoz is recalling its generic version of the heartburn drug, following reports that suggest pills may contain high amounts of the carcinogenic impurity N-Nitrosodimethylamine (NDMA).

The generic Zantac recall was announced on September 23, after federal health officials discovered certain versions of the medication contain the cancer-causing chemical, which has been linked to a risk of liver cancer, stomach cancer, colorectal cancer and other digestive tract cancers. However, Sandoz, a subsidiary of Novartis, indicates that it is unaware of any reports of illness or adverse events related to NDMA contamination with their products.

Just days earlier, Sandoz halted worldwide production of generic Zantac on September 18. That announcement came on the heels of a warning issued by the FDA on September 13, which indicated that certain forms of Zantac (ranitidine) contain NDMA.

The chemical impurity NDMA has also been linked to massive valsartan recalls over the past year, after much of the U.S. supply for that blood pressure drug was found to contain the human carcinogen following changes to the drug manufacturing process. Recalled valsartan pills have already been linked to hundreds of lawsuits involving cancer diagnosed among long-term users of the generic hypertension drug.

It now appears all forms of Zantac may contain large amounts of NDMA, and the contaminant may have been part of the the heartburn and acid reflux drug since it was first approved in 1983.

According to the FDA statement issued earlier this month, NDMA levels were detected by the online pharmacy Valisure, which found that some Zantac pills contained more than 26,000 times the amount of NDMA that the FDA deems safe to consume in one day.

The Sandoz generic Zantac recall affects all quantities and lots within the expiration date for 30 count, 60 count and 500 count bottles of Ranitidine Hydrochloride Capsules sold by Sandoz in 150mg and 300mg strength. A full list of NDC numbers, lot numbers, expiration dates and manufacturing dates are provided in the recall announcement.

“Sandoz will be notifying its distributors and customers via overnight mail and via the Sandoz webs site, and will arrange for the return of all recalled products,” the recall notice states. “Wholesalers (direct customers) will be asked to immediately stop distribution and return any stock to Sandoz, and contact the retail pharmacies in their group to do the same. Pharmacies will be asked to immediately stop dispensing Sandoz ranitidine Hydrochloride Capsules and return remaining stock to Sandoz by contacting Stericycle to request a recall packet.”

The drug maker recommends consumers continue taking their medication until they speak to a doctor or pharmacist about alternatives. Sandoz and the FDA are also requesting that any adverse events or cancer cases linked to the use of the recalled medication be reported to the FDA’s MedWatch Adverse Event Reporting program.

For individuals diagnosed with cancer, lawyers are now evaluating whether Zantac recall lawsuits may provide compensation as a result of the drug makers’ failure to warn about the presence of the cancer-causing impurity.