During routine inspection of BATCH 180G, particulate matter was observed bound to the stopper and/or present on the lyophilized cake of some vials of ERWINASE. These affected vials were segregated. There is a possibility that some remaining vials may contain particulate matter bound to the stopper and/or on the lyophilized cake, which if transferred to reconstituted ERWINASE may pose a safety risk to patients. To avoid a potential shortage of ERWINASE, Health Canada has not objected to the importation of up to 150 packs of UK-labelled product from the global Batch CAMR-180G as an interim measure.
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