FDA recall D-0248-2019

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.

Distribution

AL, AZ, CA, KS, LA, MS, OH, OR, TN, TX and Puerto Rico

Key facts

Status

Terminated

Initiation date

2018-11-08

Report date

2018-11-21

Termination date

2020-04-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0248-2019