November 2018 FDA Recall Erbitux by Eli Lilly & Co
D-0248-2019 - Labeling
This Class III drug recall was voluntarily initiated by Eli Lilly & Co on November 8, 2018 for the product Erbitux. The FDA reported the reason for recall as labeling. The product was distributed in AL, AZ, CA, KS, LA, MS, OH, OR, TN, TX and Puerto Rico and the recall is currently terminated.
Recall Number: D-0248-2019
Labeling: Missing label; potential for missing primary container label on the vial.
11-08-2018
11-21-2018
9,380 vials
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Eli Lilly & Co
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
AL, AZ, CA, KS, LA, MS, OH, OR, TN, TX and Puerto Rico
04-22-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lot number: C1700167, exp 9/2020
