Exact FDA event identifier

Event 69389

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

Event summary

Timeline bucket: September 18, 2014
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- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -count box, Rx Only, Manufactured in USA for E-Z EM, Inc. Lake Success, NY 11042 by Tower Laboratories LTD Centerbrook, CT 06409 NDC 10361-793-01

D-0014-2015

Recall number: D-0014-2015
Initiated: September 18, 2014
Classification: Class III
Status: Terminated
Recalling firm: Bracco Diagnostic Inc
Quantity: 58,050 packets

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.

Code information

Lot # F12C01; Exp. 02/15

Distribution pattern

Nationwide