Product information

MDR Number

MDR 056-09/19

Company name

Medreich PLC

Product description

Product PL Number Ranitidine 150mg Tablets 21880/0091 Ranitidine 300mg Tablets 21880/0092

Brief description of the problem

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

A full list of the batches affected are available in the attachment at the end of the document.

Advice for healthcare professionals and wholesalers

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.

For stock control enquiries please contact Medreich Plc Customer Service team on 020 8831 1580 or cs_team@medreich.co.uk

For medical information enquiries please contact Medreich Plc Pharmacovigilance Department on 020 8831 1580 or info@medreich.co.uk

Recipients should bring it to the attention of relevant contacts.

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

Download document

Class 2 Medicines Recall: Ranitidine 150mg Tablets, PL 21880/0091, Ranitidine 300mg Tablets, PL 21880/0092 (EL (20)A/05)