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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79481

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

Open FDA event record

Event summary

Timeline bucket
March 08, 2018
Product types
Drug
Classifications
Class II
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

E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured by E-Z-EM Canada Inc. for E-Z-EM Inc. a subsidiary of Bracco Diagnostics Inc., Monroe Twp., NJ 0883, NDC 32909-770-01

D-0609-2018
Recall number
D-0609-2018
Initiated
March 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Bracco Diagnostics Inc.
Quantity
2,136 tubes

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: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.

Code information

Lot # 00538529

Distribution pattern

Product was distributed throughout the United States, Hong Kong and New Zealand.