Exact FDA event identifier

Event 65756

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

Event summary

Timeline bucket: July 04, 2013
Product types: Drug
Classifications: Class II
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 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771

D-913-2013

Recall number: D-913-2013
Initiated: July 04, 2013
Classification: Class II
Status: Terminated
Recalling firm: VistaPharm, Inc.
Quantity: 1,707,050 cups / 5ml ea.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.

Code information

Lot # 240200, 243000, 244800, 245600, 250800 and 253600. Exp 06/13.

Distribution pattern

Nationwide.