During a routine visual inspection, particulate matter was observed bound to the stopper of some vials of ERWINASE (Batch CAMR-174). The global supply of ERWINASE has been affected by this ongoing issue with defective stoppers. To avoid a potential shortage of ERWINASE, Health Canada has not objected to the importation of 40 packs, plus an additional 20 packs as of September 16, 2016, of UK-labelled product from the global Batch CAMR-174 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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