Pfizer is recalling approximately 12,416 vials of Elelyso (taliglucerase alfa) for injection (200 units/vial) because the metal caps on the vials may be loose. This defect was discovered after reports that the entire cap could lift or fall off when attempting to open the orange plastic button, which compromises the sterile seal of the medication. Because this is an injectable drug, a lack of sterility can lead to serious infections for patients.
A loose or dislodged cap means the medication is no longer protected by a sterile seal, potentially allowing bacteria or other contaminants to enter the vial. If a contaminated drug is injected, it can cause severe, life-threatening infections or other systemic health complications.
Healthcare provider consultation and pharmacy refund
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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