Exact FDA event identifier

Event 68276

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

Open FDA event record

Event summary

Timeline bucket: May 12, 2014
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Bristol-Meyers Squibb

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

COUMADIN FOR INJECTION (Warfarin Sodium for Injection, USP 5 mg Single-Use Vial Rx Only Distributed by Bristol Meyers Squibb Company, Princeton, NJ 08543 USA NDC 0590-0324-96

D-1595-2014

Recall number: D-1595-2014
Initiated: May 12, 2014
Classification: Class I
Status: Terminated
Recalling firm: Bristol-Meyers Squibb
Quantity: 50,724 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: particulate matter identified as metallic-like and non-metallic cellulose fiber particles found in retain vials

Code information

Lot 00201125, Exp. 09/14; 00201126 Exp.11/14; 00201127, Exp.12/14; 00201228 Exp.06/15; 00201229 Exp. 07/15; 00201230, Exp. 09/15

Distribution pattern

Nationwide, Canada