The Zantac recall is quickly turning into a landslide as national pharmacy chains pulled Zantac and its generics from its shelves and countries from Korea to Bangladesh asked makers to remove ranitidine drugs from their markets.
CVS Sunday said it was suspending sales of all Zantac brand and CVS Health brand ranitidine products until further notice. That came despite the fact the FDA has yet to seek the recall of the products or recommend that patients quit taking the heartburn med after it warned a suspected carcinogen has been found in them.
“This action is being taken out of an abundance of caution due to a recent Product Alert from the U.S. Food and Drug Administration (FDA) that ranitidine products may contain a low level of nitrosodimethylamine (NDMA), which is a probable human carcinogen,” the national pharmacy retailer said in a statement.
It was followed on Monday by Walgreens and Rite Aid, The New York Times reported.
The action followed recalls by some drugmakers in the U.S. and moves by regulators outside of the U.S. to restrict distribution or to have markets cleared of the drugs. GlaxoSmithKline, the original developer of Zantac, as well as Sandoz, Dr. Reddy’s Laboratories and Apotex all said they were recalling their ranitidine drugs from the U.S. market.
Sanofi, which now owns the Zantac brand, has so far not taken that step.
Regulators suspended sales of the drugs in South Korea, where the industry was interpreting a remark from an official with the Ministry of Food and Drug Safety that the drugs might now be allowed to return to the market, the Korea Biomedical Review reported. A temporary ban in Bangladesh was more targeted, applying only to drugs made with APIs from India’s Saraca Laboratories and Dr Reddy's, which have found elevated levels of NDMA in their ingredients. Those moves followed Canada’s step of asking drugmakers to halt sales of the drugs there.
FDA alerted the public Sept. 13 that it had been determined that NDMA could be produced during the manufacturing of ranitidine drugs. At the time, it said the amounts found in the drugs appeared to be less than would be found in common foods, and their risks seemed small.
The FDA was alerted to the existence of the impurity in ranitidine drugs by online pharmacy Valisure, which has filed a citizen petition to force the FDA to recall the drugs and create acceptable standards and tests for NDMA for drugmakers before they are returned to the market.