Exact FDA event identifier

Event 69567

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

Event summary

Timeline bucket: October 16, 2014
Product types: Drug
Classifications: Class I
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

1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass vial (Twenty-five (25) units per box/fifty (50) units per case, NDC 0409-4279-02, Hospira, Inc., Lake Forest, IL 60045

D-0391-2015

Recall number: D-0391-2015
Initiated: October 16, 2014
Classification: Class I
Status: Terminated
Recalling firm: Hospira Inc.
Quantity: 100,100 units

App-derived interpretation

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

particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.

Code information

Lot# 40-316-DK, Exp 01APR2016

Distribution pattern

Nationwide