Recall: D-1103-2023

Class III - Minor Violations

Class IIIClassification

2023-08-14Initiated

CompletedStatus

Baxter Healthcare CorporationFirm

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

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

Distribution

Nationwide in the U.S.A.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.