MHRA Issues Teva UK Ranitidine Recall Alert

Tim Locke

October 17, 2019

A second manufacturer has issued a recall over contamination concerns for ranitidine medication.

Last week, GlaxoSmithKline recalled all unexpired stock of four types of prescription-only Zantac over N-nitrosodimethylamine (NDMA) impurities linked to cancer.

Now Teva's Ranitidine Effervescent Tablets 150 micrograms and 300 micrograms have been added to the Medicines and Healthcare products Regulatory Agency (MHRA) drug alert list over the same contamination precautions.

Stock is being quarantined but patients are being told to keep taking medication until their next routine review of treatment.

The Department of Health and Social Care (DHSC) has already issued guidance on alternative treatments.

No Recorded Harm to Patients So Far

The MHRA is working with the European Medicines Agency on the impact of the contamination.

Dr Andrew Gray, MHRA deputy director of inspections, enforcement & standards, said in a statement: "Whilst this action is precautionary, the MHRA takes patient safety very seriously."

He continued: "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.

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

"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."

Editor's Note: 25th October 2019 - today the MHRA issued two further Class 2 Medicines recalls:



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