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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 58410

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

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Event summary

Timeline bucket
March 15, 2011
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Luitpold Pharmaceuticals, 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

CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC 0517-2930-25), b) 100 mL PHARMACY BULK PACKAGE (NDC 0517-2900-25), Rx Only, AMERICAN REGENT, INC. SHIRLEY, NY 11967.

D-1378-2012
Recall number
D-1378-2012
Initiated
March 15, 2011
Classification
Class II
Status
Terminated
Quantity
30 mL: 2,078,800 vials; 100 mL: 167,100 vials

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: In the course of inspecting retention samples visual particles were observed.

Code information

30 mL Lots: 9198, 9252, 9299, 9305, 9402, 9423, 9432, 9553, 9595, 9646, 9681, 9737, 9797, 9831, 0051, 0095, 0362; 100 mL Lots: 9225, 9492, 9711, 0007, 0058

Distribution pattern

Nationwide, Puerto Rico, and Abu Dhabi

Field note

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