Exact FDA event identifier

Event 80428

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

Event summary

Timeline bucket: June 06, 2018
Product types: Drug
Classifications: Class II
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

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

Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count box (NDC 45567-0040-1), b) 30-count box, NDC 45567-0040-2 , Rx only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.

D-1040-2018

Recall number: D-1040-2018
Initiated: June 06, 2018
Classification: Class II
Status: Terminated
Recalling firm: Pharmalucence, Inc.
Quantity: 95 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of assurance of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.

Code information

Lot 4223

Distribution pattern

Nationwide