Reported Aug 30, 2023 · Completed

Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter…

Baxter Healthcare Corporation

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625

Is this the product you have?

  • Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01.
Lot codes and dates
  • Lots
    • 3A004A
    • 3A004B
    • Exp 12/31/2024
    • 3B005A
    • Exp 1/31/2025
Amount recalled
13,502 vials

Where it was sold

  • Nationwide

Why it was recalled

Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

Want the full recall guide?

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 5:08 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.