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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65244

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

Open FDA event record

Event summary

Timeline bucket
May 30, 2013
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Pharmalucence, 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

Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging. For Intravenous Use and Reconstitution. a) Five vials kits: NDC# 45567-0555-1, b) Thirty vials kits: NDC# 45567-0555-2, Rx Only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821

D-808-2013
Recall number
D-808-2013
Initiated
May 30, 2013
Classification
Class III
Status
Terminated
Recalling firm
Pharmalucence, Inc.
Quantity
17,260 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 found in retain samples

Code information

Lot 280011, Exp 08/13

Distribution pattern

Nationwide & Bahamas, Barbados, Bermuda, Japan