Exact FDA event identifier

Event 66881

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

Event summary

Timeline bucket: November 18, 2013
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Fougera Pharmaceuticals 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

KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-30, UPC 3 0168-0099-30 9.

D-1044-2014

Recall number: D-1044-2014
Initiated: November 18, 2013
Classification: Class III
Status: Terminated
Recalling firm: Fougera Pharmaceuticals Inc.
Quantity: 31,122 tubes

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 Impurities/Degradation Specifications: Out-of-Specification degradant results.

Code information

Lot #: 495P, Exp 07/14

Distribution pattern

Nationwide and Puerto Rico