- Medicines and Healthcare products Regulatory Agency
- 25 May 2016
- 25 May 2016
- Alert type:
- Drug alert
(Special Products Ltd) A batch of Epistatus 10mg in 1ml Oromucosal Solution is being recalled due to the wrong size of neck adaptor in some bottles (EL (16)A/06)
25 May 2016
Class 2 medicines recall
Action within 48 hours
Patient level recall
Special Products Limited
Epistatus 10mg in 1ml Oromucosal Solution - Unlicensed Special (Midazolam Maleate)
|Batch Number||Expiry date||Pack Size||First distributed|
|73234||Oct 2017||1 x 5ml||24 Feb 2016|
Special Products Limited is recalling the above batch because in approximately 47% of units, the neck adaptor, which reduces the size of the opening to accommodate the oral syringes, is the wrong size and is not compatible with the syringes.
Advice for healthcare professionals and patients
Healthcare Professionals are asked to quarantine any remaining stock from this batch and return it to the original supplier.
Patients or carers who may have received this batch should be contacted to notify them of this recall. 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. All unopened bottles or opened bottles with the incorrect adaptor should be returned and replaced. Please ensure that new stock is available before affected stock is returned.
For enquiries relating to stock return and medical information, please contact Special Products Limited on 01932 690 325 and follow the options.
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics, general practitioners and community pharmacists for information.
Published: 25 May 2016
Issued: 25 May 2016
Alert type: Drug alert