Exact FDA event identifier

Event 80190

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

Event summary

Timeline bucket: May 29, 2018
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Pharmaceutical Associates 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, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05

D-0865-2018

Recall number: D-0865-2018
Initiated: May 29, 2018
Classification: Class III
Status: Terminated
Recalling firm: Pharmaceutical Associates Inc
Quantity: 275400 cups

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

Resuspension problems: Out of specification for appearance and resuspendability.

Code information

Lot: B5B8 Exp. 07/2019

Distribution pattern

Nationwide