Recalls / Class III
Class IIID-1103-2023
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.
- Brand name
- Bendamustine Hydrochloride
- Generic name
- Bendamustine Hydrochloride
- Active ingredient
- Bendamustine Hydrochloride
- Route
- Intravenous
- NDC
- 10019-079
- FDA application
- NDA216078
- Affected lot / code info
- Lots: 3A004A, 3A004B, Exp 12/31/2024; 3B005A, Exp 1/31/2025
Why it was recalled
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 13,502 vials
- Distribution pattern
- Nationwide in the U.S.A.
Timeline
- Recall initiated
- 2023-08-14
- FDA classified
- 2023-08-24
- Posted by FDA
- 2023-08-30
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-1103-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.