Another major drugmaker is recalling its Zantac generics because of the possibility they contain unsafe levels of a possible carcinogen. Teva, which does not sell ranitidine products in the U.S., has recalled 10 batches of the drugs in the U.K.
The recall involves two dose sizes of ranitidine meds, U.K. health regulator Medicines and Healthcare products Regulatory Agency (MHRA) announced Thursday. Ranitidine is the generic form of the antacid Zantac,
The recall is precautionary while the agency works with other global regulators to determine the extent of the risk, Andrew Gray, MHRA deputy director of inspections, enforcement and standards, said in a statement.
“We have asked companies to quarantine batches of potentially affected medicines whilst we investigate and we will take action as necessary, including product recalls where appropriate,” Gray said. “We have also requested risk assessments from the relevant companies which will include the testing of potentially affected batches."
A Teva spokesperson in an email today confirmed the drugmaker does not sell generic Zantac in the U.S.
Some drugmakers began recalling their ranitidine globally as soon as the FDA in September alerted drugmakers and the public the drugs had been found to contain the nitrosamine impurity N-nitrosodimethylamine (NDMA). Regulators have discovered that NDMA can be formed during the manufacturing of some drugs.
Novartis’ Sandoz, followed by Apotex and Dr. Reddy’s Laboratories, went ahead and recalled their Zantac generics when the alert was first raised by the FDA. Since then, pharmacy chains CVS, Walgreens, Rite Aid and Walmart announced they would pull the over-the-counter antacids from their shelves.
The FDA has now reported that further tests found unacceptably high levels of the impurity in the drug, prompting more drugmakers to initiate voluntary recalls. Earlier this month, GlaxoSmithKline, the original developer of Zantac, said it was recalling its ranitidine from markets outside the U.S. GSK sold U.S. rights to the Zantac brand to Sanofi some years ago so does not sell ranitidine drugs in the U.S.
The FDA’s focus on NDMA began last year when it learned it was one of three suspected carcinogens that could be formed during the manufacturing of sartan blood pressure meds. The discovery precipitated a global recall of much of the valsartan, losartan and irbesartan on the market.
Those recalls have continued into this year. During the summer, Teva recalled 10 lots of losartan that were made with a tainted active pharmaceutical ingredient from Hetero Labs.
Earlier this year, online pharmacy Valisure informed the FDA tests it conducts on its drugs had determined that NDMA could also be formed during the manufacturing of ranitidine.