When Novartis decided to pull its generic Zantac off shelves Tuesday on worries the drug contained a probable carcinogen, an expanding recall of the heartburn med seemed imminent. Now other drugmakers are jumping on board, and a global recall could be approaching.
GlaxoSmithKline, the original maker of branded Zantac, has halted global distribution of its generic version of the drug and issued a voluntary recall at the retail level in India and Hong Kong, a spokeswoman said Thursday. GSK does not market its version of the drug on U.S. shelves, the company said.
The recall and supply halt stem from contaminated API sourced from two Indian suppliers—Dr. Reddy’s Laboratories and Saraca—containing-nitrosodimethylamine (NDMA), one of the suspected carcinogens tied a global recall of “sartan” based drugs over the past year.
GSK now joins Novartis’ Sandoz unit as the first large-cap drugmakers to begin recalls of generic Zantac, which is sold as an over-the-counter and prescription treatment. But other generics makers are also piling on, with four in Canada alone.
On Tuesday, Sandoz said it would voluntarily recall all lots of its 150 mg and 300 mg ranitidine hydrochloride capsules to the consumer level “because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA.”
On Thursday, Health Canada said four drugmakers were voluntarily pulling generic Zantac off the country’s shelves after the government requested the industry to do so. Those drugmakers include Apotex, Pro Doc Limitée, Sanis Health and Sivem Pharmaceuticals.
Last week, the agency said that Sandoz Canada had already announced it would recall its OTC version of the drug.
“Health Canada continues to gather and share information with other regulators, including the U.S. Food and Drug Administration and the European Medicines Agency, and with Canadian companies to better understand the issue and whether there may be a risk to Canadians,” the agency said Sept. 17.
Those company-specific distribution halts and recalls comes as national regulators around the world conduct their own investigations into Zantac and NDMA contamination.
On Tuesday, the FDA said it was testing lots of generic Zantac from “multiple manufacturers” and asked drugmakers to conduct in-house tests to determine the amount of NDMA in their versions of the drug.
“We began testing ranitidine products immediately after we learned of the potential impurity,” acting FDA Commissioner Ned Sharpless said in a statement. “When we identify lapses in the quality of drugs that pose potential risks for patients, the FDA makes all efforts to understand the issue and provide our best recommendation to the public as quickly and accurately as possible.”
The European Medicines Agency (EMA) also announced last week that it had begun a review of its own but had not issued any voluntary recalls. National regulators in Germany and Italy both announced they were investigating the drug.
NDMA was one of a group of possible carcinogens targeted by the FDA in a global recall in 2018 targeting a group of heart pressure meds including valsartan and losartan. Despite being the first compounds targeted, the FDA later discovered that N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) and NDEA—all considered unsafe at certain levels—can be created during sartan drug manufacturing under certain conditions.