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Buccolam 10mg Oromucosal solution alert

Incorrect PIL

May 23rd 2023

Tagged: MHRA alert

By MHRA

Orifarm UK Limited has advised of an incorrect PIL for Buccolam 10mg oromucosal solution (midazolam hydrochloride).

The affected batch is

Batch NoExpiry DatePack SizeFirst Distributed
62090360008/20244 pre-filled oral syringe11/04/2023

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 [email protected]