Exact FDA event identifier

Event 88505

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

Event summary

Timeline bucket: August 19, 2021
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Eli Lilly & Company

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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80

D-0773-2021

Recall number: D-0773-2021
Initiated: August 19, 2021
Classification: Class II
Status: Terminated
Recalling firm: Eli Lilly & Company
Quantity: 119,539 4-packs

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Label error

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.

Code information

Lot number: D396436C

Distribution pattern

USA Nationwide