Class 4 Caution in Use: Actilyse 20mg and 50mg powder and solvent for solution for injection and infusion (alteplase)
- The problem
- Reports that rubber stopper may be pushed into vial during reconstitution, rendering the vial unusable. (EL (16)A/11)
- What to do
- Check the batch number on your pack against the list below. Do not stop taking a prescribed medicine without talking to your pharmacist, GP or prescriber first – they can check your supply and swap it if needed.
24 August 2016
Class 4 Medicines Defect Information
Caution in Use
Distribute to Hospital Pharmacy Level
EL number
EL (16)A/11
MDR number
MDR 70-08/16
Company name
Boehringer Ingelheim Limited
Product description
Actilyse 20mg and 50mg powder and solvent for solution for injection and infusion (alteplase)
PL 00015/0120
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.
Advice for healthcare professionals
Users who experience this issue are asked to report to Boehringer Ingleheim Medical Information on 01344 742579 or medinfo.bra@boehringer-ingelheim.com.
Download document
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.
Actilyse 20mg and 50mg (EL (16)A/11)
Updated 24 August 2016. This page summarises an official notice. Details can change – always follow the official notice.