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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79802

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

Open FDA event record

Event summary

Timeline bucket
April 10, 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

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 TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC 45567-0455-2 . Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.

D-0815-2018
Recall number
D-0815-2018
Initiated
April 10, 2018
Classification
Class II
Status
Terminated
Recalling firm
Pharmalucence, Inc.
Quantity
157 units (5 count) and 464 units (30 count)

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Stability Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications

Code information

Part Number MEM05 and MEB30 both with expiry date 12/2018

Distribution pattern

US Nationwide