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
3A004A3A004BExp 12/31/20243B005AExp 1/31/2025
- Lots
- 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.
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