Bendamustine HCl Injection recall: Labeling Error
Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL…
Why was Bendamustine HCl Injection recalled?
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots: 3A004A, 3A004B, Exp 12/31/2024; 3B005A, Exp 1/31/2025
- Product
- Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL…
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 13,502 vials
- Distribution
- Nationwide in the U.S.A.
- Recall date
- August 30, 2023
- Classification
- Class III
- Status
- Completed
- Agency
- FDA (drug)