D-1103-2023 Class III
FDA drug recall D-1103-2023 was initiated by Baxter Healthcare Corporation on Aug 14, 2023 and is designated Class III. Reason for recall: Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial. Affected quantity: 13,502 vials.
Recall details
- Product Type
- Drugs
- Report Date
- Aug 30, 2023
- Initiation Date
- Aug 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,502 vials
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.
Reason for recall
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Distribution pattern
Nationwide in the U.S.A.
Code information
Lots: 3A004A, 3A004B, Exp 12/31/2024; 3B005A, Exp 1/31/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1103-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026