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.

FDA recall notice · announced August 30, 2023 · Baxter Healthcare

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Reason for recall

Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.

Notes

Distribution: Nationwide in the U.S.A.
Lot/code information: Lots: 3A004A, 3A004B, Exp 12/31/2024; 3B005A, Exp 1/31/2025
Quantity: 13,502 vials
Status: Completed
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.