Exact FDA event identifier

Event 65021

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

Event summary

Timeline bucket: April 19, 2013
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Novartis Consumer Health

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

Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tube, Novartis Consumer Health, Parsippany, NJ 07054, NDC 0067-6171-85

D-420-2013

Recall number: D-420-2013
Initiated: April 19, 2013
Classification: Class III
Status: Terminated
Recalling firm: Novartis Consumer Health
Quantity: 3,828 Tubes

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Incorrect or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.

Code information

Lot #: 10118124, Exp: Sept 2013

Distribution pattern

Nationwide