FDAClass IIINovember 21, 2018

ERBITUX CETUXIMAB Injection recall: Labeling Error

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…

Why was ERBITUX CETUXIMAB Injection recalled?

Labeling: Missing label; potential for missing primary container label on the vial.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot number: C1700167, exp 9/2020

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…
Recalling firm
Eli Lilly & Co
Quantity
9,380 vials
Distribution
AL, AZ, CA, KS, LA, MS, OH, OR, TN, TX and Puerto Rico
Recall date
November 21, 2018
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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