Xellia Pharmaceuticals recalls Micafungin 50mg vials due to missing critical package insert sections. This could affect patient safety but does not require immediate discontinuation.
Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
Xell:ia Pharmaceuticals is recalling Micafungin injection vials because the package insert lacks required sections on adverse reactions, drug interactions, and specific populations. This could lead to safety risks for patients using the medication.
The package insert missing required sections could lead to improper use or adverse reactions. Without complete information about drug interactions and specific populations, patients might experience unexpected health effects.
Patients prescribed Micafungin injections by healthcare providers. Those with specific medical conditions or taking other medications may be at higher risk due to incomplete information.
Check for Micafungin 50mg/vial, single-dose vials with NDC 70594-036-01 and lot number 467111. The product was manufactured for intravenous use only and sold with a specific expiration date of January 2023.
Verify if the package insert includes all required sections for adverse reactions, drug interactions, and use in specific populations.
The recall is due to missing package insert sections, not an immediate safety hazard. Patients should check if their package insert is complete.
No immediate stop is required. Patients should check the package insert for completeness before use.
Check if your package insert includes all required sections. If missing, contact your healthcare provider for guidance.
We’ve drafted a message you can send Xellia Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0756-2021 — Xellia Pharmaceuticals Xellia Pharmaceuticals Hello, I own a Xellia Pharmaceuticals that is covered by recall D-0756-2021 from Xellia Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
