FDAFDA · Food and drugs·Recall number D-1103-2023
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.
Published August 30, 2023 · Recall initiated: August 14, 2023
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BENDAMUSTINE HYDROCHLORIDE
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- Nationwide in the U.S.A.
- Lot
- Lots: 3A004A, 3A004B, Exp 12/31/2024; 3B005A, Exp 1/31/2025
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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