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:
- Stop supplying the affected products immediately
- Quarantine all remaining stock and return it to your supplier using their agreed process
- 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.