Status
Completed
Drug Enforcement D-1103-2023
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Classification
Class III
Report Date
August 30, 2023
Termination Date
—
Product Information
- 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.
- Product quantity
- 13,502 vials
- Reason for recall
- Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the U.S.A.
Location & Firm
- Recalling firm
- Baxter Healthcare Corporation
- Address
-
1 Baxter Pkwy, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1103-2023
- Event ID
- 92887
- Recall initiation date
- August 14, 2023
- Center classification date
- August 24, 2023
- Code info
- Lots: 3A004A, 3A004B, Exp 12/31/2024; 3B005A, Exp 1/31/2025
- More code info
- —