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

Caution in Use: Distribute to Pharmacy, Hospital, GP, Dental Practice, Ward and Clinic Level.

Product information

MDR number

MDR 134-10/17

Company name


Product description

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

Marketing Authorisation number

  • EU/1/11/709/001
  • EU/1/11/709/002
  • EU/1/11/709/003
  • EU/1/11/709/004

Brief description of the problem

Shire has distributed the Direct Healthcare Professional Communication (DHCP) attached 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.

This issue is applicable to all unexpired batches of BUCCOLAM currently in the marketplace.

Actions for healthcare professionals

As outlined in the DHCP attached, 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


Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to relevant clinics, hospital pharmacists, general practitioners, dental practices, dentists, nurses, neurologists, neurology specialist nurses, epilepsy specialist nurses and community pharmacists for information.

The DHCP letter has been circulated to a number of patient support groups.

Download document

Class 4 Drug Alert - Buccolam (midazolam) Buccal Solution - MDR 134-10/17

Published 7 December 2017
Last updated 8 December 2017 + show all updates
  1. Added information for dental practices.

  2. First published.