Drug product
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.
D-1103-2023
Product summary
- Event
- Event 92887
- Status
- Completed
- Classification
- Class III
- Quantity
- 13,502 vials
- Official record key
drug-enforcement:D-1103-2023
Official wording
Reason: Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Code information: Lots: 3A004A, 3A004B, Exp 12/31/2024; 3B005A, Exp 1/31/2025
Distribution pattern: Nationwide in the U.S.A.
Derived failure modes
-
Labeling or packaging
Labeling: Missing