Xellia Pharmaceuticals recalls Micafungin 100mg vials due to missing critical package insert sections. This could affect patient safety information. Consumers should contact the company for details.
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.
Xellia Pharmaceuticals is recalling Micaf:ungin for Injection vials because the package insert lacks required sections on adverse reactions, drug interactions, and specific populations. This could lead to safety risks if patients don't have complete instructions.
The package insert doesn't include all required sections about adverse reactions, drug interactions, and use in specific populations. This means patients might not get complete safety information, potentially leading to unsafe use.
Healthcare providers and patients using this medication for intravenous infusion. Those with specific medical conditions or taking other medications may be at higher risk.
Check for Micafungin for Injection 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, manufactured by Xellia Pharmaceuticals USA, LLC. Look for NDC 70594-037-01 and lot number 467111 (expires 1/2023).
Verify the package insert includes all required sections for adverse reactions, drug interactions, and specific populations.
The recall is due to missing critical safety information in the package insert, but the product itself is not unsafe. Patients should check the package insert for complete instructions.
Look for Micafungin 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, with NDC 70594-037-01 and lot 467111 (expires 1/2023).
The recall does not require immediate action. Check the package insert for completeness and contact Xellia Pharmaceuticals for further 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-0757-2021 — Xellia Pharmaceuticals Xellia Pharmaceuticals Hello, I own a Xellia Pharmaceuticals that is covered by recall D-0757-2021 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.
