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
Reported: November 21, 2018 Initiated: November 8, 2018 #D-0248-2019
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.
Details
- Recalling Firm
- Eli Lilly & Co
- Units Affected
- 9,380 vials
- Distribution
- AL, AZ, CA, KS, LA, MS, OH, OR, TN, TX and Puerto Rico
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Eli Lilly & Co. Units affected: 9,380 vials.
Why was this product recalled? ▼
Labeling: Missing label; potential for missing primary container label on the vial.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 21, 2018. Severity: Low. Recall number: D-0248-2019.
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