ERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use vial, Rx only, Manufa...
FDA Recall #D-0248-2019 — Class III — November 8, 2018
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.
Recalling Firm
Eli Lilly & Co — Indianapolis, IN
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
9,380 vials
Distribution
AL, AZ, CA, KS, LA, MS, OH, OR, TN, TX and Puerto Rico
Code Information
Lot number: C1700167, exp 9/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated