Sandoz recalled 14 lots of Ranitidine capsules for exceeding the FDA’s limits on a probable carcinogen, a substance that can cause cancer.
That substance in this case, NDMA (N-Nitrosodimethylamine), also has caused the recall of numerous heart and blood pressure medications since July 2018.
Ranitidine, Sandoz’s recall notice says, treats “duodenal ulcer, benign gastric ulcer, reflux esophagitis, post-operative peptic ulcer, Zollinger-Ellison Syndrome, and other conditions where reduction of gastric secretion and acid output is desirable.”
Ranitidine is also sold in over-the-counter form and known by the brand name Zantac.
This recall includes Ranitidine 150 mg capsules in 60 and 500-count bottles with lot Nos. HD1862, HP9438, HP9439, HP9440, HP9441, HC9266, HD1865, JK7994, JK8659; and 300 mg capsules in 30-count bottles with lot Nos. HD8625, HD9275, HU2207, HX6676 and HX6677.
People with recalled Ranitidine should consult with their doctor or pharmacist about an alternate course of treatment before stopping medicine use.
Consumers with questions about the recall can call Sandoz, 800-525-8747, hit the # sign button, Monday through Friday, 8:30 a.m. to 5 p.m., Eastern time. Or, you can go to the Sandoz website by clicking here.
To report an adverse event to the FDA, go to the adverse event reporting part of the FDA website; download a reporting form by clicking here; or call 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 800-FDA-0178