Updated Class 4 drug alert: Crescent Pharma Ltd and Flamingo Pharma Ltd – Ibuprofen 400mg tablets various batch numbers

The updated alert highlights further affected batches. Where possible, affected packs should be considered for dispensing against a prescription rather than sold over the counter to safeguard patients from taking a prescription only dose.

SPS commentary:

Patient Information Leaflets in the affected batches incorrectly state that “the maximum daily dose should not exceed 6 [six] tablets (2400 mg)”. This dosing regimen should only be given to patients who are under the supervision of their GP or healthcare prescriber and have been prescribed ibuprofen 400mg tablets.


Medicines and Healthcare products Regulatory Agency