Exact FDA event identifier

Event 71442

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

Event summary

Timeline bucket: May 27, 2015
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Bracco Diagnostic 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

E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Canada Inc. a subsidiary of E-Z-EM Inc., Lake Success NY NDC 32909-727-01

D-1147-2015

Recall number: D-1147-2015
Initiated: May 27, 2015
Classification: Class III
Status: Terminated
Recalling firm: Bracco Diagnostic Inc
Quantity: 1008 boxes

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.

Code information

Lot #: 00513716, 00514712, Exp 03/2016

Distribution pattern

Nationwide