Erbitux Solution
FDA Recall NDC 66733-948
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Erbitux (NDC 66733-948). A significant event, classified as Class III, was initiated on Nov 08, 2018 by Imclone Llc. The reported reason for this action was: "Labeling: Missing label; potential for missing primary container label on the vial."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Labeling: Missing label; potential for missing primary container label on the vial.
Nov 08, 2018
Nov 21, 2018
9,380 vials
Recall Profile & Regulatory Data
Event ID
81511
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Eli Lilly & Co
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
AL, AZ, CA, KS, LA, MS, OH, OR, TN, TX and Puerto Rico
Termination Date
Apr 22, 2020
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
Batch or Lot Expiration Information
Lot# Lot number: C1700167, exp 9/2020
Affected Packages Involved in this Recall
66733-948-23Product
66733-958-23Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
