Class 2 Medicines recall: Zantac Injection 50mg/2ml, Zantac Syrup 150mg/10ml, Zantac Tablets 150mg, Zantac Tablets 300mg (EL (19)A 24)

GlaxoSmithKline, trading as Glaxo Welcome Ltd, is recalling all unexpired stock of Zantac (ranitidine hydrochloride) prescription only medicines (POM) from pharmacies.

From:
Medicines and Healthcare products Regulatory Agency
Published
8 October 2019
Message type:
Medicines recall/notification
Medical specialty:
Anaesthetics, Cardiology, Care home staff, Cosmetic surgery, Critical care, Dentistry, General practice, General surgery, Haematology and oncology, Infection prevention, Obstetrics and gynaecology, Ophthalmology, Orthopaedics, Paediatrics, Pathology, Pharmacy, Physiotherapy and occupational therapy, Radiology, Renal medicine, Theatre practitioners, Urology, Vascular and cardiac surgery
Issued:
8 October 2019

Product information

GlaxoSmithKline is recalling all unexpired stock of Zantac (ranitidine hydrochloride) prescription only medicines (POM) from pharmacies as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.

Product PL Number
Zantac Syrup 150mg/10ml 10949/0108
Zantac Injection 50mg/2ml 10949/0109
Zantac Tablets 150mg 10949/0042
Zantac Tablets 300mg 10949/0043

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 ongoing 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.

Company contacts for further information

For stock control enquiries please refer to the GSK website or contact 0800-221-441.

For medical information enquiries please contact ukmedinfo@gsk.com, via the Live Chat facility or on 0800 221 441 (option 2).

Recipients of this Drug Alert 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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EL (19)A 24

Updates to this page

Published 8 October 2019
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