Zantac Injection 50mg/2ml, Zantac Syrup 150mg/10ml, Zantac Tablets 150mg, Zantac Tablets 300mg (EL (19)A 24)
- The problem
- GlaxoSmithKline, trading as Glaxo Welcome Ltd, is recalling all unexpired stock of Zantac (ranitidine hydrochloride) prescription only medicines (POM) from pharmacies.
- What to do
- Check the batch number on your pack against the list below. Do not stop taking a prescribed medicine without talking to your pharmacist, GP or prescriber first – they can check your supply and swap it if needed.
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.
Download document
Updated 8 October 2019. This page summarises an official notice. Details can change – always follow the official notice.