US Drug Recall Register
Class III · Low risk Terminated Initiated Nov 8, 2018 (8 years ago)

ERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use vial, Rx…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Labeling: Missing label; potential for missing primary container label on the vial.

What was recalled

ERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use vial, Rx only, Manufactured by: ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, Branchburg, NJ 08876 USA. NDC: 66733-958-23

Recalling firm
Eli Lilly & Co
Origin
IN, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0248-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.