Class 4 Caution in Use: Actilyse 20mg and 50mg powder and solvent for solution for injection and infusion (alteplase)

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

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)

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