Sanofi UK is initiating an
urgent recall of two batches of Targocid 200mg powder for solution for
injection/infusion or oral solution (Batch Number 0J25D1 and Batch Number 0J25D2).
This
is due to out of specification results obtained for bacterial endotoxins, which
has been confirmed through testing of retain samples. This issue was observed
following a medical adverse event, which reported that four patients
experienced high grade of fever approximately three hours post-administration
of vials from the impacted batches.
Due
to the out of specification results observed there is a potential life
threatening or serious risk to patient health.
This National Patient Safety Alert contains further information and actions for providers.