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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67262

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

Open FDA event record

Event summary

Timeline bucket
December 16, 2013
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Bracco Diagnostics 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

VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a subsidiary or E-Z-EM, Inc. Lake Success, NY 11042. NDC 32909-945-03.

D-1083-2014
Recall number
D-1083-2014
Initiated
December 16, 2013
Classification
Class III
Status
Terminated
Recalling firm
Bracco Diagnostics Inc
Quantity
54,648 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed Stability Testing: This product is below specification for preservative content.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Testing: This product is below specification for preservative content.

Code information

Lot #: 67603, Expiry: 2/2014

Distribution pattern

Nationwide including Puerto Rico