Class 4 Medicines Defect Information: Orifarm UK Ltd, Buccolam 10mg Oromucosal solution

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 4 Medicines Defect Information for Orifarm UK Ltd, Buccolam 10mg Oromucosal solution. Orifarm UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in a specific batch of Buccolam 10mg Oromucosal solution has missing information regarding having to break the seal on the inner container before use.

Further information, advice and details of the affected batch can be found on the MHRA website.