Exact FDA event identifier

Event 67045

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

Event summary

Timeline bucket: October 11, 2013
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

0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.

D-395-2014

Recall number: D-395-2014
Initiated: October 11, 2013
Classification: Class II
Status: Terminated
Recalling firm: Hospira Inc.
Quantity: 65109 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of assurance of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.

Code information

Lot #32-484-EV, 32-485-EV Exp: 2/2015.

Distribution pattern

US Nationwide.