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Recall Observatory FDA recall evidence

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

August 14, 2023

Class III

Product summary

Firm
Baxter Healthcare Corporation
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

    reason.labeling_packaging · v1.0.0

    Labeling: Missing