Epistatus 10mg in 1ml Oromucosal Solution - fault with neck adaptor

(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

MDR 079-05/16

Product details

Special Products Limited

Epistatus 10mg in 1ml Oromucosal Solution - Unlicensed Special (Midazolam Maleate)

  • Batch number: 73234
  • Expiry date: Oct 2017
  • Pack size: 1 x 5ml
  • First distributed: 24 Feb 2016

Alert details

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.

Further information

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.

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Special Products Ltd - Epistatus Midazolam 10mg in 1ml Oromucosal EL(16)A/06

Published 25 May 2016