Drug alert issued for Epistatus Oromucosal Solution 10mg/ml
May 31 2016
A drug recall for a batch of the specials product Epistatus (midazolam maleate) 10mg/ml Oromucosal Solution 5ml has been issued. The affected batch of the unlicensed product has batch number 73234 with expiry date October 2017, and was first distributed from February 24 2016.
Specials Products Ltd has issued the recall due to concerns that around half of the units have been supplied with the wrong sized neck adaptor. The device is intended to reduce the size of the opening to accommodate an oral syringe, but as it is the wrong size it will be incompatible with the syringe.
The MHRA is asking health professionals to alerts patients who may have been supplied with the affected batch. “Where a dose has already been taken from a bottle and the correct adaptor was in place, there is no need to return that unit,” says the notice.
“All unopened bottles or opened bottles with the incorrect adaptor should be returned and replaced.” However, pharmacies should ensure that new stock is available before any affected stock is returned.
Further information is available from Special Products Ltd on 01932 690325.