FDA-Drug2023-08-30Class III

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.

Baxter Healthcare Corporation
Hazard

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

Sold states
Nationwide in the U.S.A.
Affected count
13,502 vials
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
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.

Official notice

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

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