Class 2 medicines recall drug alert of Zantac (POM) products

08 Oct 2019

Patient safety update: Class 2 recall of Zantac products – actions to take for pharmacy teams dispensing/supplying these products

A Class 2 medicines recall drug alert (Ref: EL(19)A/24) has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA) for all unexpired stock of four Zantac products listed in the table below — this is a pharmacy level recall alert which requires action within 48 hours of the alert being issued on 8 October 2019:

Zantac product Product licence (PL) number
Zantac Syrup 150mg/10ml PL 10949/0108
Zantac Injection 50mg/2ml PL 10949/0109
Zantac Tablets 150mg Pl 10949/0042
Zantac Tablets 300mg PL 10949/0043

GlaxoSmithKline is recalling all unexpired stock of Zantac prescription-only-medicines (POM) from pharmacies due to potential contamination of the active ingredient in Zantac (ranitidine) with N-nitrosodimethylamine (NDMA) as an impurity — this is a precautionary measure as NDMA has genotoxic and carcinogenic potential. The MHRA’s press release provides further details about this drug alert.

Advice for healthcare professionals, including pharmacy teams

Pharmacists and pharmacy teams are required to:

  1. Stop supplying the affected products immediately
  2. Quarantine all remaining stock and return it to their supplier using their agreed process
  3. Provide the following advice to patients making enquiries about the issue:
    • Do not stop taking their medicines – stopping treatment can pose more of a health risk than the contaminant presents
    • Patients do not need to see their doctor until their next routine appointment/treatment review
    • Speak to their doctor if they have concerns

GSK can be contacted as below:

It is important to note that an MHRA investigation into other potentially affected products is continuing. The MHRA is working with the European Medicines Agency (EMA) and other medicines regulators to determine any possible impact. The MHRA will provide further updates as the investigation progresses.

Please note: the following over-the-counter Zantac products have not been affected by the recall as they are produced by a different company:

  • Zantac 75 Relief (PL 02855/0081)
  • Zantac 75 Tablets (PL 02855/0082)

NPA patient safety support

  • The NPA patient safety section of our website is freely accessible as part of the NPA’s Medication Safety Officer (MSO) role for independent pharmacies in England with fewer than 50 branches.

NPA Members are advised to contact the Pharmacy Services team on 01727 891800 or email pharmacyservices@npa.co.uk for further advice and support.

Produced by the NPA Pharmacy Services team October 2019.