Rosemont Pharmaceuticals Limited is recalling unexpired stock from pharmacies as a precautionary measure due to possible contamination with an impurity.
Rosemont Pharmaceuticals Limited (part of the Perrigo group)
Ranitidine 150mg/10ml Oral Solution (PL 00427/0132)
Brief description of the problem
Rosemont Pharmaceuticals Limited is recalling all unexpired stock of the above products from pharmacies as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.
Advice for healthcare professionals
- Stop supplying the above products immediately. 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 not to stop taking their medication as the health risk of discontinuing the medicine is higher than the potential risk presented by the contaminant. A treatment review is not necessary until the next routine appointment.
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.
Source – MHRA