Public recall detail

Erwinase for Injection - Replacement with UK Labelled Stock

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Recall Safety notice
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Quick summary: Erwinase for Injection - Replacement with UK Labelled Stock .

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Recall details

Quick summary: Erwinase for Injection - Replacement with UK Labelled Stock .

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 routine visual inspection of ERWINASE Batches CAMR-180, 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 of 25 packs of UK-labelled product from the global Batch CAMR-180, sub-lot CAMR-180aG117 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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