Why it was recalled
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Product description
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 numbers, UPCs & expiration codes
Lots: 3A004A, 3A004B, Exp 12/31/2024; 3B005A, Exp 1/31/2025
Where it was sold
Nationwide in the U.S.A.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1103-2023
- Classification
- Class III
- Status
- Completed
- Recall initiated
- Aug 14, 2023
- FDA report date
- Aug 30, 2023
- Quantity
- 13,502 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corporation
Original FDA data
Every field from FDA enforcement report D-1103-2023, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Completed
- Country
- United States
- Event ID
- 92887
- Address
- 1 Baxter Pkwy
- Code information
- Lots: 3A004A, 3A004B, Exp 12/31/2024; 3B005A, Exp 1/31/2025
- Postal code
- 60015-4625
- Report date
- Aug 30, 2023
- Product type
- Drugs
- Recall number
- D-1103-2023
- Classification
- Class III
- Recalling firm
- Baxter Healthcare Corporation
- Product quantity
- 13,502 vials
- Reason for recall
- Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the U.S.A.
- Recall initiation date
- Aug 14, 2023
- Initial firm notification
- Letter
- Center classification date
- Aug 24, 2023