Exact FDA event identifier

Event 85226

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

Event summary

Timeline bucket: March 19, 2020
Product types: Drug
Classifications: Class II
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

DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg vial, Rx only, Manufactured for: Jubilant Draximage, Inc., Kirkland, Quebec, Canada, NDC 65174-288-05, 67175-288-30

D-1062-2020

Recall number: D-1062-2020
Initiated: March 19, 2020
Classification: Class II
Status: Terminated
Recalling firm: Jubilant Draximage Inc
Quantity: 473 kits of 30 vials

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

Lot # 8K143, Exp 10/31/2020.

Distribution pattern

Product was distributed throughout the United States.