Home / Recalls / Hill Dermaceuticals, Inc. / D-217-2013

D-217-2013 Class III Terminated

Recalled by Hill Dermaceuticals, Inc. — Sanford, FL

FDA drug recall D-217-2013 was initiated by Hill Dermaceuticals, Inc. on November 21, 2012 and is designated Class III. Reason for recall: Subpotent; 12 month stability timepoint The recall status is terminated (terminated May 28, 2013). Affected quantity: 8,736 bottles.

Recall Details

Product Type: Drugs
Report Date: April 3, 2013
Initiation Date: November 21, 2012
Termination Date: May 28, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8,736 bottles

Product Description

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

Reason for Recall

Subpotent; 12 month stability timepoint

Distribution Pattern

Nationwide

Code Information

Lot J111040, Exp. (09/13)

Other recalls by Hill Dermaceuticals, Inc.

D-0637-2021 Class II — DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx onl (May 21, 2021)
D-1177-2014 Class III — ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), (January 31, 2014)
D-1173-2014 Class III — DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Ma (January 31, 2014)
D-1174-2014 Class III — Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. oz. (January 31, 2014)
D-1181-2014 Class III — SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx onl (January 31, 2014)
D-1178-2014 Class III — ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 (January 31, 2014)
D-1176-2014 Class III — ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (January 31, 2014)
D-1179-2014 Class III — SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 f (January 31, 2014)
D-1175-2014 Class III — Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., (January 31, 2014)
D-1180-2014 Class III — SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl. (January 31, 2014)