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

FDA recall notice · announced November 21, 2018 · Eli Lilly & Co

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: AL, AZ, CA, KS, LA, MS, OH, OR, TN, TX and Puerto Rico
Lot/code information: Lot number: C1700167, exp 9/2020
Quantity: 9,380 vials
Status: Terminated
Products in this recall event:
- 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. N (D-0248-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.