During routine inspection of Batch 181G, 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.
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