Recalls / Class III
Class IIID-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
- Brand name
- Erbitux
- Generic name
- Cetuximab
- Active ingredient
- Cetuximab
- Route
- Intravenous
- NDCs
- 66733-948, 66733-958
- FDA application
- BLA125084
- Affected lot / code info
- Lot number: C1700167, exp 9/2020
Why it was recalled
Labeling: Missing label; potential for missing primary container label on the vial.
Recalling firm
- Firm
- Eli Lilly & Co
- Manufacturer
- ImClone LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Lilly Corporate Ctr, Indianapolis, Indiana 46285-0001
Distribution
- Quantity
- 9,380 vials
- Distribution pattern
- AL, AZ, CA, KS, LA, MS, OH, OR, TN, TX and Puerto Rico
Timeline
- Recall initiated
- 2018-11-08
- FDA classified
- 2018-11-15
- Posted by FDA
- 2018-11-21
- Terminated
- 2020-04-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0248-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.