FDA-Drug2018-11-21Class III

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

Eli Lilly & Co
Hazard

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

Sold states
AL, AZ, CA, KS, LA, MS, OH, OR, TN, TX and Puerto Rico
Affected count
9,380 vials
Manufactured in
1 Lilly Corporate Ctr, Indianapolis, IN, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0248-2019

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