← FDA ENFORCEMENT
D-1103-2023Class III

Baxter Healthcare Corporation

Recalling firm
Baxter Healthcare Corporation
Product type
Drug
Status
Completed
Report date
2023-08-30
Distribution
Nationwide in the U.S.A.
Firm state
IL
Product quantity
13,502 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

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

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.

Code / lot info

Lots: 3A004A, 3A004B, Exp 12/31/2024; 3B005A, Exp 1/31/2025

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.