A low level incidence of cracked vials has been detected at the Worthing manufacturing site affecting Augmentin 1.2g presentation in 25cc tubular glass vials.

Patient safety is our first concern and so (he company has consulted with the UK regulatory agency and has proposed the distribution ot a DHCP letter advising healthcare providers to examine units before use. as per the included dosing instruction, and to discard the unit if the reconstituted liquid is NOT colourless or pale, straw in colour. This approach was endorsed by the Defective Medicines Reporting Centre pMRC), who has issued a Class IV 'Caution in Use' notification

The issue only applied to Augmentin 25cc TUBULAR glass vials.

GSK is currently conducting a thorough investigation. The investigation has so far identified That the damage is being caused by glass-on-glass impact potentially during a transportation event prior to the packaging stage on site.

The site will ensure the required actions are implemented to prevent this situation occurring again.

Please be informed that there is MO GSK REQUIREMENT TO RECALL product from the market

Based on above information, please advise, if DHCP [Dear Healthcare Professional) letter should be distributed locally as per local safety requirements.