The Medicines and Healthcare products Regulatory Agency (MHRA) on Monday issued a class two medicines recall for all unexpired stocks of ranitidine 150 mg and 300 mg tablets by Medreich Plc.
The latest announcement, following recalls of ranitidine products of several drug makers since October, too comes as a precautionary measure due to the possible contamination with an impurity N-nitrosodimethylamine (NDMA), which has genotoxic and carcinogenic potential.
Pharmacists are asked to stop supplying the recalled products immediately and remove from the store shelves. The stocks should be returned to the supplier through their approved process.
MHRA said the agency is actively involved with the European Medicines Agency and other medicines regulators to determine the possible impact of this on-going issue.
“An investigation into other potentially impacted products is continuing and further updates will be provided as the investigation progresses,” the MHRA statement read.
In October, GlaxoSmithKline (GSK) and Teva UK have recalled their ranitidine products soon after US, Swiss and German regulators found “unacceptable” levels of NDMA in the popular heartburn drug.
In November 2019, Medreich Plc recalled all unexpired batches of ranitidine 75mg tablets from pharmacies and retail stores.
Creo Pharma, Tillomed Laboratories, Omega Pharma Limited, Galpharm International, Rosemont Pharmaceuticals, OTC Concepts Ltd, Relconchem Ltd and Noumed Life Sciences Ltd have also recalled their ranitidine products.
Product details:
| Product | PL Number |
| Ranitidine 150mg Tablets | 21880/0091 |
| Ranitidine 300mg Tablets | 21880/0092 |
