PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: November 21, 2018 Initiated: November 8, 2018 #D-0248-2019

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Eli Lilly & Co
Units Affected
9,380 vials
Distribution
AL, AZ, CA, KS, LA, MS, OH, OR, TN, TX and Puerto Rico
Location
Indianapolis, IN

Frequently Asked Questions

What product 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. Recalled by Eli Lilly & Co. Units affected: 9,380 vials.
Why was this product recalled?
Labeling: Missing label; potential for missing primary container label on the vial.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 21, 2018. Severity: Low. Recall number: D-0248-2019.