News » MHRA alert » Buccolam 10mg Oromucosal solution alert
May 23rd 2023
Orifarm UK Limited has advised of an incorrect PIL for Buccolam 10mg oromucosal solution (midazolam hydrochloride).
The affected batch is
| Batch No | Expiry Date | Pack Size | First Distributed |
| 620903600 | 08/2024 | 4 pre-filled oral syringe | 11/04/2023 |
The correct PIL contains instructions in step one to break the seal on the inner container before use. All other sections of the PIL are unaffected.
Step 1 (correct PIL)
Healthcare professionals are advised to inform patients that there is an error in the PIL. Corrected PILs are available from the manufacturer. The affected batch is not being recalled.
For more information, medical or supply enquiries, please contact 01276 698370, or email uk_enquiries@orifarm.com
