Class 2 Medicines recall: Ranitidine 150mg and 300mg Film-Coated Tablets (Accord Healthcare)

Class 2 Medicines recall: Ranitidine 150mg and 300mg Film-Coated Tablets (Accord Healthcare)

December 5, 2019

Drug alert number: EL (19)A/40

Date issued: 5 December 2019

Accord Healthcare are recalling all unexpired stock of the products listed below 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 20075/0063
Ranitidine 300mg Film-Coated Tablets 20075/0064

Advice for healthcare professionals and retail stores
• Stop supplying the above products immediately and remove from shelves in 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.

View the full Drug Alert here.

Company contacts for further information

For stock control enquiries contact Accords Customer Service team: 0800 373573
For medical information enquiries contact Accords Pharmacovigilance Department: 01271 385257 or medinfo@accord-healthcare.com



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