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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81511

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 08, 2018
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Eli Lilly & Co

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-0248-2019
Recall number
D-0248-2019
Initiated
November 08, 2018
Classification
Class III
Status
Terminated
Recalling firm
Eli Lilly & Co
Quantity
9,380 vials

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Missing label; potential for missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot number: C1700167, exp 9/2020

Distribution pattern

AL, AZ, CA, KS, LA, MS, OH, OR, TN, TX and Puerto Rico