D-0248-2019 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 21, 2018
- Initiation Date
- November 8, 2018
- Termination Date
- April 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,380 vials
Product Description
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 Pattern
AL, AZ, CA, KS, LA, MS, OH, OR, TN, TX and Puerto Rico
Code Information
Lot number: C1700167, exp 9/2020