Exact FDA event identifier

Event 92916

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

Event summary

Timeline bucket: August 30, 2023
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: VistaPharm 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

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

Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-305-16

D-1149-2023

Recall number: D-1149-2023
Initiated: August 30, 2023
Classification: Class II
Status: Terminated
Recalling firm: VistaPharm LLC
Quantity: 14,400 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/Subpotent single ingredient Drug: Out of Specification Assay results

Code information

Lot #: 921100; Exp. 02/2025

Distribution pattern

Distributed nationwide to 68 consignees in the U.S.