Exact FDA event identifier

Event 69285

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

Event summary

Timeline bucket: September 15, 2014
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: AbbVie Inc

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

CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottles, Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064, Product of Germany. NDC 0032-1224-07.

D-1611-2014

Recall number: D-1611-2014
Initiated: September 15, 2014
Classification: Class II
Status: Terminated
Recalling firm: AbbVie Inc
Quantity: 18,021 Bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

Foreign Tablets

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.

Code information

Lot #: 1020156; Expiry: 3/31/2016

Distribution pattern

US: Nationwide