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(Adds context on U.S. FDA move)
Oct 8 (Reuters) - GlaxoSmithKline Plc is recalling
its heartburn medicine Zantac as a "precautionary measure" due
to a probable cancer-causing impurity in the drug, Britain's
medicines watchdog said on Tuesday.
The move follows the U.S. Food and Drug Administration
discovery last week of "unacceptable levels" of a cancer-causing
impurity in Zantac and its generic versions known chemically as
ranitidine.
GSK is recalling all unexpired stock of Zantac from
pharmacies due to possible contamination with an impurity
N-nitrosodimethylamine (NDMA), the Medicines and Healthcare
products Regulatory Agency (MHRA) said https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-zantac-injection-50mg-2ml-zantac-syrup-150mg-10ml-zantac-tablets-150mg-zantac-tablets-300mg-el-19-a-24.
The company was not immediately available for a comment.
U.S. and European health regulators said last month they
were reviewing the safety of ranitidine, after online pharmacy
Valisure flagged the impurities to regulators. Canada's health
authorities have also asked makers of the drug to halt
distribution as they gathers more information.
The FDA, which checked the over-the-counter drugs using a
low-heat method of testing, said it found much lower levels of
the impurity NDMA than was discovered with a higher temperature
test employed by Valisure.
For a related timeline:
(Reporting by Justin George Varghese in Bengaluru; editing by
Deepa Babington)
