REGULATORY INTELLIGENCE·Recall
Pfizer's Elelyso Recall: Sterility Assurance Failure Impacts Global Supply of Taliglucerase Alfa
Pfizer Inc. initiated a Class II recall of 24,714 vials of Elelyso (taliglucerase alfa) due to loose vial crimps compromising sterility. This voluntary action, impacting US and international markets, highlights critical packaging quality control failures. For decision-makers, it underscores the imperative for robust supplier qualification and vigilant oversight to mitigate supply chain disruptions and ensure product integrity.
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