Exact FDA event identifier

Event 64455

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: November 21, 2012
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Hill Dermaceuticals, 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

2 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 2

Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc., Sanford, Florida 32773 --- NDC 28105-150-04

D-217-2013

Recall number: D-217-2013
Initiated: November 21, 2012
Classification: Class III
Status: Terminated
Recalling firm: Hill Dermaceuticals, Inc.
Quantity: 8,736 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent; 12 month stability timepoint

Code information

Lot J111040, Exp. (09/13)

Distribution pattern

Nationwide

drug · product 2 of 2

Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE, Net Contents 118.28 mL (4 fl. oz.), Hill Dermaceuticals, Inc., Sanford, Florida --- NDC 28105-149-04

D-218-2013

Recall number: D-218-2013
Initiated: November 21, 2012
Classification: Class III
Status: Terminated
Recalling firm: Hill Dermaceuticals, Inc.
Quantity: 8,592 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent; 22 month stability timepoint

Code information

Lot # D110550, Exp. 04/2013.

Distribution pattern

Nationwide