Standard: Statement of Policy Intent: Early Access to Innovative Medical Devices

Ipca Laboratories UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the products listed in this notification do not contain all the required safety information.

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

Sterling Pharmaceuticals Ltd and Veriton Pharma Ltd are recalling all batches of KidNaps (Melatonin) 1mg in 1ml Oral Solution due to out of specification stability results.  

Aspar Pharmaceuticals Ltd is recalling specific batches distributed in Aspar, Almus and Numark livery. The batches are being recalled as a precautionary measure following findings of foil perforations in some blisters.

Baxter Healthcare is recalling one batch of Compound Sodium Lactate (Hartmann’s Solution) 1000mL. This is due to a packaging error where some cartons labelled as Hartmann’s Solution may contain Ringer’s Solution 1000mL.

The Access Consortium — comprising regulatory authorities from the UK, Australia, Canada, Singapore and Switzerland — works together to streamline regulatory processes, support innovation and improve global public health outcomes.