Company Halts Ranitidine Production Over NDMA Contamination Concerns
After some lots of ranitidine were found to contain small amounts of N-nitrosodimethylamine (NDMA), Novartis's Sandoz unit has announced that they are halting distribution of ranitidine (Zantac) products until the contamination concerns are resolved.
Novartis's Sandoz unit has announced that they are halting distribution of generic ranitidine (Zantac), after some lots of ranitidine were found to contain small amounts of N-nitrosodimethylamine (NDMA).1
Used in both OTC and prescription drugs, ranitidine is a histamine-2 blocker which decreases the amount of acid produced in the stomach. NDMA is classified as a probable human carcinogen, and is a known contaminant found in water and foods.
The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medications since 2018, but the findings in ranitidine medications was just discovered earlier in September.2
While Sandoz said an internal investigation is working to determine further details, they are proactively halting distribution of Zantac until a solution is found, according to a report.
The FDA did not specify which particular products were affected, and the generic drug is available from companies besides Sandoz. The agency has not ordered a recall at this point, and said that the levels found during preliminary tests barely exceed amounts normally found in common foods.2
- Dabaie M. Novartis's Sandoz Halting Ranitidine Distribution. Morningstar. https://www.morningstar.com/news/dow-jones/201909186653/novartiss-sandoz-halting-ranitidine-distribution. Published September 18, 2019. Accessed September 20, 2019.
- Statement alerting patients and health care professionals of NDMA found in samples of ranitidine. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine. Published September 13, 2019. Accessed September 20, 2019.