Class 4 MHRA drug alert – BUCCOLAM (midazolam) Oromucosal Solution Pre-filled Syringes

Class 4 MHRA drug alert – BUCCOLAM (midazolam) Oromucosal Solution Pre-filled Syringes

December 8, 2017

Class 4 Medicines Defect Information: BUCCOLAM (midazolam) Oromucosal Solution Pre-filled Syringes

Date issued: 7th December 2017

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 drug alret for:

BUCCOLAM (midazolam) 2.5 mg, 5 mg, 7.5 mg and 10 mg Oromucosal Solution Pre-filled Syringes

Brief description of the problem

Shire has distributed the Direct Healthcare Professional Communication (DHCP) (see here) due to reports that the translucent tip-cap sometimes remains on the syringe tip when pulling the red cap off, as shown in the DHCP diagrams.

If this occurs, the translucent tip cap needs to be removed manually to enable administration of BUCCOLAM and to prevent it falling into the patient’s mouth upon application of extreme pressure. There have not yet been any reports of the translucent tip-cap falling into a patient’s mouth but this cannot theoretically be excluded.

Please note this issue is applicable to all unexpired batches of BUCCOLAM currently in the marketplace.

Actions for healthcare professionals

As outlined in the DHCP, we ask you share this information with your patients’ parents and caregivers, and with age-appropriate patients, during your interactions with them going forward to ensure they are aware of this issue when handling the product.

Company contact information

Should you have any questions or require additional information on the use of BUCCOLAM 2.5 mg, 5 mg, 7.5 mg and 10 mg oromucosal solution, please contact:

Medical Information
Tel: 0800 055 6614
Email: MedinfoEMEA@shire.com

To view the alert please visit the GOV.uk website.



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