Over-the-counter Zantac recalled

Sanofi is voluntarily recalling all sizes of Zantac OTC (over-the-counter) in the U.S. and Canada because it may be contaminated with a nitrosamine impurity called Nnitrosodimethylamine (NDMA) which is believed to be carcinogenic in humans, according to a recall notice from the Defense Commissary Agency’s food safety office sent Oct. 21.

The U.S Food and Drug Administration (FDA) and Health Canada issued public statements on Sep. 13 alerting that some ranitidine medicines, including Zantac OTC, could contain NDMA at low levels and asked manufacturers to conduct testing. Due to inconsistencies in preliminary test results of the active ingredient used in the U.S. and Canadian products, Sanofi decided to conduct the voluntary recall in the U.S. and Canada.

Their ranitidine products outside the U.S. and Canada are not affected by this recall since they are sourced from different suppliers.

The Defense Commissary Agency has publicized this recall to all its stores, said Richard Stith, Chief, Public Health Division, DeCA headquarters at Fort Lee, Virginia. Whenever a commissary has recalled or withdrawn products in its inventory, they are immediately removed from store shelves.           

The following product is affected by this recall:

• Zantac OTC, All sizes

Sanofi urges anyone using Zantac OTC to speak with their health care provider or pharmacist.

Customers should return this product to the commissary of purchase for a full refund.

Consumers with questions may contact Ashleigh Koss at (908) 981-8745 or via email at Ashleigh.Koss@sanofi.com.