Drug Alert: Epistatus, Midazolam 10mg in 1ml Buccal Liquid x 5ml (M11) - EL(12)A/08
The British Dental Association has been made aware of a MHRA alert on the above product manufactured by Special Products Ltd.
|Batch Number||Expiry Date||First Distributed|
|25658||October 2013||5 December 2011|
|27229||November 2013||20 January 2012|
Special Products Ltd carried out several modifications to this unlicensed product in December 2011. Information about the changes appears not to have been adequately passed on to users of the product and has the potential to result in product overdose. The two batches above have been distributed with the following changes to the oral dosing pipettes:
- Removal of the luer tip
- Extension of the markings on the plunger from 1.0ml to 1.5ml
- Repositioned plunger stop allowing delivery of 1.5ml (the previous pipette stopped at 1.0ml)
The bottle adaptor has been modified for compatibility with the new dosing pipette. The new dosing pipette does not fit the previous bottle adaptor and neither does the old dosing pipette fit the new adaptor. There is a potential for overdose if users rely on the syringe stop rather than using the graduations and are unaware that potential dose has increased from 1.0 to 1.5 ml.
Please ensure the pipette graduations are used instead of relying on the plunger stop irrespective of the batch number(s) they have available. Special Products Ltd plan to revert to the previous syringe with a potential maximum dose of 1.0ml at the earliest opportunity. This is expected to be available from mid April 2012. This product is distributed via wholesalers and Community Pharmacists. For further information please contact Special Products Ltd Medical Information Enquiries on 01932 690325, e-mail: firstname.lastname@example.org