MHRA Class 4 Medicines Defect Information: Buccolam 10mg Oromucosal solution (Orifarm UK Ltd)

Class 4 Medicines Defect Information:

Buccolam 10mg Oromucosal solution (Orifarm UK Ltd)

Drug alert number: EL (23)A/18

Date issued: 22 May 2023

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:

Product name: Buccolam 10mg Oromucosal solution (Orifarm UK Ltd) PLGB 45985/0272

Batch No Expiry Date Pack Size First Distributed
620903600 08/2024 4 pre-filled oral syringe 11/04/2023

Active Pharmaceutical Ingredient: midazolam hydrochloride

Brief description of the problem

Orifarm UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in one batch of Buccolam 10mg Oromucosal solution has missing information regarding having to break the seal on the inner container before use. All other sections of the PIL are unaffected.

The information in step 1 of the PIL should include text indicating to break the seal at one end:

Step 1 (incorrect PIL)

Step 1 (correct PIL)

Advice for healthcare professionals

Healthcare professionals are advised to inform patients that there is an error in the PIL. The information regarding breaking the seal on the inner container before use as per ‘Step 1 (correct PIL)’ as shown in the images in this notification, should be followed.

The Marketing Authorisation Holder can supply copies of the correct PIL on request, so that any affected packs remaining in the dispensary can be supplemented with the correct information. Future copies of the PIL will reflect the correct information.

View full alert here.

Further Information

For more information, medical or supply enquiries, please contact 01276 698370, or email uk_enquiries@orifarm.com

Support the call for more funding by recording information about the informal advice you provide to patients over just one day.

Click Here