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Source: Medicines & Healthcare products Regulatory Agency (MHRA)

 

Summary

Accord Healthcare is recalling all unexpired stock of the above products from pharmacies and wholesalers as a precautionary measure due to possible contamination with an impurity Nnitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.

Product

PL Number

Ranitidine 150mg Film-Coated Tablets

PL 20075/0063

Ranitidine 300mg Film-Coated Tablets

PL 20075/0064

 

Advice for healthcare professionals and retail stores

  • Stop supplying the above products immediately and remove from the shelves within your store. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

 

  • If you receive queries about this issue from patients, advise them to contact their GP, pharmacist or healthcare professional to review ongoing treatment.

 

This is an on-going issue and the MHRA is actively involved with the European Medicines Agency and with other medicines regulators to determine any possible impact. An investigation into other potentially impacted products is continuing and further updates will be provided as the investigation progresses.

 

Action within

48 hours of reading this alert

 

Action by

Pharmacy and wholesalers

 

» Click here to read the full CAS alert