Class 2 medicines recall – Action within 48 hours – Pharmacy level recall: Ranitidine oral solution 150mg/10ml EL (19)A/29

25 Oct 2019

Class 2 medicines recall – Action within 48 hours – Pharmacy level recall: Ranitidine oral solution 150mg/10ml EL (19)A/29

DRUG ALERT

Class 2 medicines recall – Action within 48 hours – Pharmacy level recall: Ranitidine oral solution 150mg/10ml EL (19)A/29

25 October 2019

Ranitidine oral solution 150mg/10ml
(Rosemont Pharmaceuticals Limited)

PL 00427/0132

A Class 2 medicines recall has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for all unexpired stock of Ranitidine oral solution 150mg/10ml manufactured by Rosemont Pharmaceuticals Limited. This is a pharmacy level recall alert which pharmacies are required to action within 48 hours of the alert being issued on 25 October 2019

Pharmacists and pharmacy teams are required to:

  1. Stop supplying the affected products immediately
  2. Quarantine all remaining stock and return it to your 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

The above recall is part of an ongoing issue of potential contamination of all oral ranitidine products with N-nitrosodimethylamine (NDMA) as an impurity.

Further information can be found on the MHRA section on the GOV.UK website.

Produced by the NPA Pharmacy Services team October 2019.