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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66147

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

Open FDA event record

Event summary

Timeline bucket
August 30, 2013
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

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

Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4164-03, UPC (01) 0 030409 416403 8.

D-461-2014
Recall number
D-461-2014
Initiated
August 30, 2013
Classification
Class I
Status
Terminated
Recalling firm
Hospira Inc.
Quantity
17,256 containers

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: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.

Code information

Lot# 26-138-JT; Exp. 08/14

Distribution pattern

Nationwide