Reports that rubber stopper may be pushed into vial during reconstitution, rendering the vial unusable. (EL (16)A/11)
24 August 2016
Class 4 Medicines Defect Information
Caution in Use
Distribute to Hospital Pharmacy Level
Boehringer Ingelheim Limited
Actilyse 20mg and 50mg powder and solvent for solution for injection and infusion (alteplase)
Brief description of the problem
There have been an increased number of complaints where the rubber stopper has been pushed into the vial during reconstitution. This renders the vial unusable. Boehringer Ingelheim Limited have provided guidance to Healthcare Professionals on the handling of the transfer cannula.
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.