CLASS III Drug recall · Reported 21 Nov 2018 · FDA Enforcement Report
Erbitux Cetuximab Injection, 200 mg/ (2 mg/mL) per single-use vial recalled
Eli Lilly is recalling Erbitux Cetuximab Injection, 200 mg/ (2 mg/mL) per single-use vial, distributed in 11 states. The recall was initiated on 8 Nov 2018 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0248-2019
- FDA event ID
- 81511
- Recalling firm
- Eli Lilly, Indianapolis, IN
- Brand
- Erbitux
- Manufacturer
- ImClone LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 8 Nov 2018
- FDA classified
- 15 Nov 2018
- Reported
- 21 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Injectable & IV Drugs
Timeline
| 8 Nov 2018 | Recall initiated by company | |
| 15 Nov 2018 | Classified by FDA | +7 days |
| 21 Nov 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Missing label; potential for missing primary container label on the vial.
Product as listed by the FDA
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
Where it was distributed
AL, AZ, CA, KS, LA, MS, OH, OR, TN, TX and Puerto Rico
AlabamaArizonaCaliforniaKansasLouisianaMississippiOhioOregonPuerto RicoTennesseeTexas
Questions about this recall
Why was it recalled?
Labeling: Missing label; potential for missing primary container label on the vial.
Which lots are affected?
Lot number: C1700167, exp 9/2020
Where was it sold?
AL, AZ, CA, KS, LA, MS, OH, OR, TN, TX and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Cetuximab recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cetuximab 335 MG / Ivpb recalled by Infusion Options | Infusion Options | Sterility | NY |