Contamination Potential Leads UK to Fifth Recall of Ranitidine Drugs

Regulatory NewsRegulatory News | 21 November 2019 |  By 

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday announced the fifth recent recall of the heartburn medicine ranitidine due to possible contamination with the carcinogen N- nitrosodimethylamine (NDMA).
The recall, which affects 13 over-the-counter (OTC) ranitidine medicines marketed by four different companies, follows four previous recalls in October and November and comes as international regulators including the US Food and Drug Administration (FDA) and European Medicines Agency investigate the source of the impurities.
FDA previously said the levels of the impurity in ranitidine drugs for heartburn and also in the chemically similar ulcer drug nizatidine “are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.”
Three of the companies affected by the recall, OTC Concepts Ltd, Relonchem Ltd and Noumed Life Sciences Ltd are recalling all unexpired batches of the drug, while the fourth company, Medreich PLC is only recalling specific batches.
As with the previous recalls, MHRA says its action is precautionary to ensure patient safety and advises patients to continue taking their medicines as advised and speak to their physician before stopping any prescribed medicine.
“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,” said MHRA Deputy Director of Inspections, Enforcement & Standards Andrew Gray.
Gray also said that MHRA has asked the companies to submit risk assessments containing testing of the affected batches as part of its investigation.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy