FDA recall D-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.

Reason for recall

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

Distribution

Nationwide in the U.S.A.

Key facts

Status

Completed

Initiation date

2023-08-14

Report date

2023-08-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1103-2023