Why it was recalled
Labeling: Missing label; potential for missing primary container label on the vial.
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
Lot numbers, UPCs & expiration codes
Lot number: C1700167, exp 9/2020
Where it was sold
AL, AZ, CA, KS, LA, MS, OH, OR, TN, TX and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0248-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 8, 2018
- FDA report date
- Nov 21, 2018
- Quantity
- 9,380 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eli Lilly & Co
Original FDA data
Every field from FDA enforcement report D-0248-2019, exactly as published.
Show all FDA fields
- City
- Indianapolis
- State
- IN
- Status
- Terminated
- Country
- United States
- Event ID
- 81511
- Address
- 1 Lilly Corporate Ctr
- Code information
- Lot number: C1700167, exp 9/2020
- Postal code
- 46285-0001
- Report date
- Nov 21, 2018
- Product type
- Drugs
- Recall number
- D-0248-2019
- Classification
- Class III
- Recalling firm
- Eli Lilly & Co
- Product quantity
- 9,380 vials
- Termination date
- Apr 22, 2020
- Reason for recall
- Labeling: Missing label; potential for missing primary container label on the vial.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- AL, AZ, CA, KS, LA, MS, OH, OR, TN, TX and Puerto Rico
- Recall initiation date
- Nov 8, 2018
- Initial firm notification
- Letter
- Center classification date
- Nov 15, 2018