FDA Drug recall D-0248-2019
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 sub…
- FDA Drug
- Class III
- terminated
- Published 2018-11-21
On 2018-11-21 the FDA classified a Class III recall of 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 sub… by Eli Lilly And, citing labeling: Missing label; potential for missing primary container label on the vial.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0248-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-11-08 |
| Published | 2018-11-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Eli Lilly And |
| Distribution | AL, AZ, CA, KS, LA, MS, OH, OR, PR, TN, TX |
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
Labeling: Missing label; potential for missing primary container label on the vial.
Identifiers
| ndc | 66733-948-23 |
|---|---|
| ndc | 66733-958-23 |
| code_info | Lot number: C1700167, exp 9/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0248-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.