The Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday issued a class 2 level medicines recall for four types of Zantac preparations made by GlaxoSmithKline, as a “precaution”.
The latest move comes just days after the U.S. Food and Drug Administration found “unacceptable’ levels of probable cancer-causing impurity in the popular heartburn drug.
The company led-global recall cites possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.
The products recalled are Zantac Syrup 150mg/10ml, Zantac Injection 50mg/2ml, Zantac Tablets 150mg and Zantac Tablets 300mg.
“GSK informed the MHRA of our decision to suspend the release, distribution and supply of all dose forms of Zantac products,” a company spokesman told Reuters.
The government agency said it was also investigating other potentially impacted products and will provide further updates as the investigation progresses.
“This is an on-going issue and the MHRA is actively involved with the European Medicines Agency and with other medicines regulators to determine any possible impact,” an MHRA statement read.
Over-the-counter 75 mg dosage Zantac products are produced by a different company and not affected by the recall, the agency added.
Community pharmacy teams are asked to quarantine all remaining stocks of these four batches of Zantac products and return it through the suppliers’ approved process.
Earlier this year, MHRA recalled three batches of Accord’s Losartan tablets as a precautionary measure due to possible contamination with the nitrosamine N-nitroso-N-methylamino butyric acid (NMBA).
Last year, MHRA also recalled batches of Valsartan containing tablets, after possible NDEA and NDMA contamination was found in the drug.
(With Reuters inputs)