Drug 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
D-0248-2019
Product summary
- Firm
- Eli Lilly & Co
- Event
- Event 81511
- Status
- Terminated
- Classification
- Class III
- Quantity
- 9,380 vials
- Official record key
drug-enforcement:D-0248-2019
Official wording
Reason: Labeling: Missing label; potential for missing primary container label on the vial.
Code information: Lot number: C1700167, exp 9/2020
Distribution pattern: AL, AZ, CA, KS, LA, MS, OH, OR, TN, TX and Puerto Rico
Derived failure modes
-
Labeling or packaging
Labeling: Missing label; potential for missing