UK Alerts to Teva Recall of Heartburn Medicines Over Impurity Fears

Regulatory NewsRegulatory News | 17 October 2019 |  By 

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday alerted to a recall of its heartburn medicine ranitidine following similar recalls due to possible contamination with an impurity called NDMA (N-nitrosodimethylamine), which may increase the risk of cancer.

For health professionals, the MHRA says to stop supplying the products immediately and quarantine all remaining stock and return it to suppliers.

Andrew Gray, MHRA deputy director of inspections, enforcement and standards added: “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.”

GlaxoSmithKline earlier this month also recalled all unexpired stock of four types of Zantac, which is the brand name for ranitidine.

Both the European Medicines Agency and the US Food and Drug Administration began investigating NDMA levels in ranitidine medicines last month.

Following those announcements, Sandoz announced a recall of 14 lots of its prescription ranitidine capsules because of the NDMA impurity. And Apotex voluntarily recalled, on a precautionary basis, its ranitidine medicines. Dr Reddy’s Laboratories and other generic drugmakers also suspended supplies of its ranitidine medicines worldwide as a precautionary measure.

CVS pharmacies also suspended the sale of all Zantac brand and other ranitidine products until further notice. Walgreens and Rite Aid made similar moves.


© 2023 Regulatory Affairs Professionals Society.

Tags: EMA, FDA, MHRA, Sandoz, Teva, Zantac

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