ERBITUX CETUXIMAB Injection — Class III drug recall D-0248-2019
Terminated recall by Eli Lilly & Co, reported 2018-11-21, distributed in AL, AZ, CA, KS, LA, MS, OH, OR…. Labeling: Missing label; potential for missing primary container label on the vial.
| Recall number | D-0248-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Eli Lilly & Co, Indianapolis, IN, United States |
| Recall initiated | 2018-11-08 |
| Classified | 2018-11-15 |
| Reported by FDA | 2018-11-21 |
| Terminated | 2020-04-22 |
| Distributed | AL, AZ, CA, KS, LA, MS, OH, OR, PR, TN, TX |
| Quantity | 9,380 vials |
| Reason classes | labeling |
| NDC | 66733-0948, 66733-0948-23, 66733-0958, 66733-0958-23 |
| Lot numbers | C1700167 |
| Expiration dates | 2020-09 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0248-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.