7th March, 2016

Co-amoxiclav 600mg & 1.2g Vials – Reconstitution Colour (PL31745/0024-0025)

In the last two weeks we have received customer calls regarding the correct appearance for reconstituted Co-amoxiclav Powder for solution for injection or infusion.  If the product is reconstituted in accordance with the details in the Patient Information Leaflet (PIL), the colour of the resulting solution will be ‘a clear, colourless or pale straw coloured solution’.  It is also important to note that in the initial stages of the reconstitution process a transient pink colour might or might not be produced in the solution.

All Co-amoxiclav products might or might not develop this transient pink colour during reconstitution. The pink colour will fade to leave a clear, colourless or pale straw coloured solution and the resulting clear solution should be administered by intravenous injection within 20 minutes of reconstitution.  We are aware that our current PIL does not refer to this transient pink colour and we are taking steps to correct this as soon as possible.  Should you have any questions regarding this issue you can obtain a full statement from our medical information department on 01483 212151 or email to medinfo@bowmed.com