Exact FDA event identifier

Event 74399

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

Event summary

Timeline bucket: June 23, 2016
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Hospira 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

Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32

D-1359-2016

Recall number: D-1359-2016
Initiated: June 23, 2016
Classification: Class II
Status: Terminated
Recalling firm: Hospira Inc.
Quantity: 373,850 tubes

App-derived interpretation

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

particulate

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Crystallization: Product contains particulate identified to be crystallized active ingredient.

Code information

Lot #: 52610LL, Exp. 01 OCT 2016; Lot #: 57660LL, Exp. 01 MAR 2017

Distribution pattern

Nationwide