Presence of Particulate Matter: Potential for glass delamination from the vials.
Presence of Particulate Matter: Potential for glass delamination from the vials.
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send American Regent, Inc. to request your refund or repair — edit it as you like.
Subject: Recall D-0081-2025 — American Regent, Inc. American Regent, Inc. recalls Venofer (iron sucrose) Injection, USP 50 mg Ele Hello, I own a American Regent, Inc. recalls Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, that is covered by recall D-0081-2025 from American Regent, Inc.. 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.
