Exact FDA event identifier

Event 86486

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

Event summary

Timeline bucket: September 25, 2020
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: VistaPharm, 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

NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816,

D-0019-2021

Recall number: D-0019-2021
Initiated: September 25, 2020
Classification: Class III
Status: Terminated
Recalling firm: VistaPharm, Inc.
Quantity: 14,244 16 oz bottles

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 Impurties/Degradation Specifications: out of specification results for an impurity for one lot

Code information

Lots: 638800 Exp 10/21

Distribution pattern

Distributed Nationwide in the USA including Puerto Rico