Baxter recalls Bendamustine HCl injection vials with missing or peeled labels. This could lead to incorrect dosing if the label is damaged. Affected vials have specific lot numbers and expiration dates.
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Baxter is recalling Bendamustine HCl injection vials that have missing or peeled labels. This could cause incorrect dosing if the label is damaged, which is serious for patients using the medication.
The vials have missing or partially peeled labels, which could lead to incorrect dosing. This is especially risky for patients who rely on the label to know the correct dose and expiration date.
Patients prescribed Bendamustine HCl injection by a doctor are affected. Those using the medication without proper labeling are at higher risk of incorrect dosing.
Check for vials with lot numbers 3A004A, 3A004B (expiring 12/31/2024) or 3B005A (expiring 1/31/2025). The product is a 4mL multiple-dose vial for prescription use.
Inspect the vial for missing or peeled labels. If labels are damaged, stop using the vial.
The product is safe if the label is intact. If the label is missing or peeled, it should not be used.
Check the label condition. If damaged, stop using it and contact your doctor for alternative options.
Look for lot numbers 3A004A, 3A004B (expiring 12/31/2024) or 3B005A (expiring 1/31/2025).
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall D-1103-2023 — Baxter Baxter Hello, I own a Baxter that is covered by recall D-1103-2023 from Baxter. 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.
