Exact FDA event identifier

Event 67420

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

Event summary

Timeline bucket: January 31, 2014
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

9 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 9

DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-160-20

D-1173-2014

Recall number: D-1173-2014
Initiated: January 31, 2014
Classification: Class III
Status: Terminated
Recalling firm: Hill Dermaceuticals, Inc.
Quantity: 4,080 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 Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

Code information

12H028B exp. 01/14

Distribution pattern

Nationwide and Puerto Rico

drug · product 2 of 9

Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. oz., Rx only. Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-149-04

D-1174-2014

Recall number: D-1174-2014
Initiated: January 31, 2014
Classification: Class III
Status: Terminated
Recalling firm: Hill Dermaceuticals, Inc.
Quantity: 14,226 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 Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

Code information

12J030C exp. 03/14, 12L041C exp. 05/14

Distribution pattern

Nationwide and Puerto Rico

drug · product 3 of 9

Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-150-04

D-1175-2014

Recall number: D-1175-2014
Initiated: January 31, 2014
Classification: Class III
Status: Terminated
Recalling firm: Hill Dermaceuticals, Inc.
Quantity: 8,734 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 Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

Code information

13D010A exp. 10/14.

Distribution pattern

Nationwide and Puerto Rico

drug · product 4 of 9

ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. for: Royal Pharmaceuticals NDC 68791-101-04

D-1176-2014

Recall number: D-1176-2014
Initiated: January 31, 2014
Classification: Class III
Status: Terminated
Recalling firm: Hill Dermaceuticals, Inc.
Quantity: 8,734 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 Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

Code information

13E013A exp. 11/14.

Distribution pattern

Nationwide and Puerto Rico

drug · product 5 of 9

ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals for: Royal Pharmaceuticals NDC 68791-102-04

D-1177-2014

Recall number: D-1177-2014
Initiated: January 31, 2014
Classification: Class III
Status: Terminated
Recalling firm: Hill Dermaceuticals, Inc.
Quantity: 7,292 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 Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

Code information

13E014A exp. 11/14, 13F02C exp 12/14.

Distribution pattern

Nationwide and Puerto Rico

drug · product 6 of 9

ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20

D-1178-2014

Recall number: D-1178-2014
Initiated: January 31, 2014
Classification: Class III
Status: Terminated
Recalling firm: Hill Dermaceuticals, Inc.
Quantity: 13,379 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 Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

Code information

13F015B exp. 12/14, 13G023B exp. 01/15

Distribution pattern

Nationwide and Puerto Rico

drug · product 7 of 9

SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-507-04

D-1179-2014

Recall number: D-1179-2014
Initiated: January 31, 2014
Classification: Class III
Status: Terminated
Recalling firm: Hill Dermaceuticals, Inc.
Quantity: 4,142 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 Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

Code information

13F015C exp. 12/14.

Distribution pattern

Nationwide and Puerto Rico

drug · product 8 of 9

SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-506-04

D-1180-2014

Recall number: D-1180-2014
Initiated: January 31, 2014
Classification: Class III
Status: Terminated
Recalling firm: Hill Dermaceuticals, Inc.
Quantity: 7,676 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 Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

Code information

13F016A exp. 12/14.

Distribution pattern

Nationwide and Puerto Rico

drug · product 9 of 9

SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-508-20

D-1181-2014

Recall number: D-1181-2014
Initiated: January 31, 2014
Classification: Class III
Status: Terminated
Recalling firm: Hill Dermaceuticals, Inc.
Quantity: 13,591 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 Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

Code information

13F017B exp. 12/14, 13F020B exp 12/14

Distribution pattern

Nationwide and Puerto Rico