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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77478

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

Open FDA event record

Event summary

Timeline bucket
June 12, 2017
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Sanofi-Aventis U.S. LLC

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

Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Tablets, 80 mg & 14.2 mg, 100-count bottles, Distributed by: GlaxoSmithKline Consumer Healthcare, L.P., Moon Twp, PA 15108, UPC 3 0088-1175-47 8.

D-0926-2017
Recall number
D-0926-2017
Initiated
June 12, 2017
Classification
Class III
Status
Terminated
Recalling firm
Sanofi-Aventis U.S. LLC
Quantity
2980 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug: high out-of-specification result for magnesium.

Code information

Lot #: 5J69A, Exp 02/19; 6GF2A, 6GF3A, Exp 08/19

Distribution pattern

Nationwide in the USA, Puerto Rico, and the United Kingdom.