During routine visual inspection of ERWINASE Batches CAMR-183, CAMR-184 and CAMR-185, particulate matter was observed bound to the stopper and/or present on the lyophilized cake of some vials. The global supply of ERWINASE has been affected by this ongoing issue with particulate matter. To help manage the impact of the ongoing shortage of ERWINASE, Health Canada has not objected to the importation and release of 60 packs of UK-labelled product from the global Batches CAMR-183a, CAMR-184a, CAMR-185a, sub-lots CAMR-183aG117, CAMR-184aG117, and CAMR-185aG117 as an interim measure. A standard 5-micron filter needle should be used to withdraw the reconstituted product from the UK-labelled product prior to administration.
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