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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Eli Lilly & Co: Erbitux (cetuximab) Injection Recalled for Missing Vial Labels

Agency Publication Date: November 15, 2018
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Summary

Eli Lilly & Co has recalled approximately 9,380 vials of Erbitux (cetuximab) Injection, a prescription medication. The recall was initiated because some vials may be missing their primary container labels, which means critical information about the medication, dosage, and expiration date would not be visible on the vial itself. This issue affects Erbitux 200 mg/100 mL single-use vials that were distributed to healthcare providers in several states and Puerto Rico.

Risk

A missing label on a medication vial poses a risk of medication errors, as healthcare providers might be unable to verify the drug name, concentration, or expiration date before administration. Using an unidentified or incorrect medication could lead to serious adverse health consequences or ineffective treatment.

What You Should Do

  1. Check your medical supplies for Erbitux (cetuximab) Injection, 200 mg/100 mL (2 mg/mL) in 100 mL single-use vials.
  2. Verify the identifying codes on the product packaging: look for NDC number 66733-958-23 and Lot number C1700167 with an expiration date of 9/2020.
  3. Immediately inspect all vials within this lot to ensure the primary container label is present and securely attached to the vial.
  4. If you find a vial with a missing or detached label, do not use the product. Contact your healthcare provider or pharmacist immediately for guidance.
  5. Contact Eli Lilly & Co at 1-800-LillyRx (1-800-545-5979) for specific instructions on how to return any affected product for a refund or replacement.
  6. Report any adverse reactions or quality problems to the FDA's MedWatch program or call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmacy refund and healthcare consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: ERBITUX (cetuximab) Injection (200 mg/100 mL)
Model:
NDC: 66733-958-23
Recall #: D-0248-2019
Lot Numbers:
C1700167 (exp 9/2020)
Date Ranges: exp 9/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81511
Status: Resolved
Manufacturer: Eli Lilly & Co
Sold By: healthcare providers; hospitals; pharmacies
Manufactured In: United States
Units Affected: 9,380 vials
Distributed To: Alabama, Arizona, California, Kansas, Louisiana, Mississippi, Ohio, Oregon, Tennessee, Texas, Puerto Rico

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.