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MHRA announces recall of 13 over-the-counter ranitidine medicines

Four companies are recalling batches of certain over-the-counter ranitidine medicines used to treat conditions such as stomach ulcers and heartburn.

A drug alert has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA) to retailers and healthcare professionals as four companies are recalling batches of certain over-the-counter (OTC) ranitidine medicines.

OTC Concepts Ltd, Relconchem Ltd and Noumed Life Sciences Ltd are recalling all unexpired batches of the products listed in the alert here from pharmacies and retail stores. Medreich PLC is recalling specific batches from pharmacies and retail stores.

The recall is a precautionary measure due to possible contamination of N-nitrosodimethylamine (NDMA), which has been identified as a potential risk factor in the development of certain cancers.

“Whilst this action is precautionary, the MHRA takes patient safety very seriously,” said Dr Andrew Gray, MHRA Deputy Director of Inspections, Enforcement & Standards. “Patients should keep taking their current medicines but should speak to their doctor or pharmacist if they are concerned and should seek their doctor’s advice before stopping any prescribed medicines.”

The recall affects 13 separate ranitidine products and retailers have been advised to stop supplying the recalled products immediately and for all remaining stock to be quarantined and returned without delay to the supplier.

“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 continued. “We have also requested risk assessments from the relevant companies which will include the testing of potentially affected batches.

…retailers have been advised to stop supplying the recalled products immediately and for all remaining stock to be quarantined and returned”

“Currently, there is no evidence that medicines containing nitrosamines have caused any harm to patients, but the Agency is closely monitoring the situation and working with other Regulatory Agencies around the world.”

The MHRA has said it is actively involved with the European Medicines Agency (EMA) and other medicines’ regulators to determine the impact of what is an ongoing, global issue.

This recall follows four previous recalls on 8 October17 October25 October and 19 November regarding the withdrawal of other ranitidine products, also recalled as a precautionary measure.

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