Class 2 Medicines recall: Ranitidine 150mg/10ml Oral Solution (EL (19)A/29)

Product information

PL number

PL 00427/0132

MDR Number

MDR 56-09/19

Company name

Rosemont Pharmaceuticals Limited (part of the Perrigo group)

Product description

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.

Further Information

For stock control enquiries please contact Perrigo Customer Service team on +44 (0)1226 704711 or customerservice@perrigouk.com

For medical information enquiries please contact Perrigo Pharmacovigilance Department on +44 (0)203 598 9603 or UKLOCustomerService@perrigo.com

Recipients should bring it to the attention of relevant contacts by copy of this letter.

NHS Regional teams are asked to forward this to relevant clinics, general practitioners and community pharmacists.

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Class 2 Medicines recall: Ranitidine 150mg/10ml Oral Solution