Exact FDA event identifier

Event 73653

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

Event summary

Timeline bucket: March 18, 2016
Product types: Drug
Classifications: Class I
Statuses: Ongoing
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

8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02

D-0865-2016

Recall number: D-0865-2016
Initiated: March 18, 2016
Classification: Class I
Status: Ongoing
Recalling firm: Hospira Inc.
Quantity: 72,000 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: particulate matter identified as an insect in one vial.

Code information

Lot # 56-148-EV, Exp 8/1/2017

Distribution pattern

Nationwide