Exact FDA event identifier

Event 73586

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

Event summary

Timeline bucket: March 11, 2016
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Jubilant Draximage 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

SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05

D-0812-2016

Recall number: D-0812-2016
Initiated: March 11, 2016
Classification: Class III
Status: Terminated
Recalling firm: Jubilant Draximage Inc
Quantity: 90 vials (450 capsules)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Label Error

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Error on Declared Strength

Code information

Lot Number 1670123; Exp 04/16

Distribution pattern

Nationwide