Exact FDA event identifier

Event 64267

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

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Event summary

Timeline bucket: January 31, 2013
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Gilead Sciences, 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

Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, UPC 3 61958 01011 5; NDC 61958-0101-1.

D-324-2013

Recall number: D-324-2013
Initiated: January 31, 2013
Classification: Class I
Status: Terminated
Recalling firm: Gilead Sciences, Inc.
Quantity: 3,181 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 was found in some vials of Vistide (cidofovir injection).

Code information

Lot #: B120217A, Exp 05/15 - US Distribution

Distribution pattern

Nationwide in USA, Canada, and UK (Gilead facility in Cork Ireland). Cork facility distributed to Germany/Austria, Italy and Spain.