Public recall detail

ERWINASE (Erwinia L-asparaginase) for Injection - Replacement with UK Labelled Stock and Shortage

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Recall Safety notice
Quick summary

Quick summary: ERWINASE (Erwinia L-asparaginase) for Injection - Replacement with UK Labelled Stock and Shortage .

Recommended action

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Recall details

Quick summary: ERWINASE (Erwinia L-asparaginase) for Injection - Replacement with UK Labelled Stock and Shortage .

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

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Issue

During a routine visual inspection, particulate matter was observed bound to the stopper of some vials of ERWINASE (Batch CAMR-177). Vials of ERWINASE with visible particulate matter need to be discarded. 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 facilitated the importation of 50 packs of UK-labelled product from the global Batch CAMR-177 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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Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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