Eli Lilly & Co recalls ERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use vial, Rx only, Manufactured by: ImClone LLC…

Recall date

November 8, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0248-2019

FDA classification

Class III

Brand / firm

Eli Lilly & Co

Sold / distributed

AL, AZ, CA, KS, LA, MS, OH, OR, TN, TX and Puerto Rico

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

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