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Hill Dermaceuticals, Inc.

FDA Regulatory Profile

Summary

Total Recalls
17
510(k) Clearances
0
Inspections
8
Compliance Actions
4

Recent Recalls

NumberClassProductDate
D-0637-2021Class IIDermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by:May 21, 2021
D-1178-2014Class IIIROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only ManufaJanuary 31, 2014
D-1175-2014Class IIIDerma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only ManufactureJanuary 31, 2014
D-1180-2014Class IIISETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl.oz., Rx only ManufaJanuary 31, 2014
D-1173-2014Class IIIDermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured and DistrJanuary 31, 2014
D-1174-2014Class IIIDerma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. oz., Rx only. ManufactJanuary 31, 2014
D-1176-2014Class IIIROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz.January 31, 2014
D-1177-2014Class IIIROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only January 31, 2014
D-1181-2014Class IIISETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only Manufactured by: HJanuary 31, 2014
D-1179-2014Class IIISETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl.oz., Rx only ManufJanuary 31, 2014
D-007-2014Class IIIDerma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Scalp Oil), 118.28 mL (4 Fl. oz.) bottlSeptember 8, 2013
D-008-2014Class IIIDerma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl. oz.) bottlSeptember 8, 2013
D-610-2013Class IIIDerma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) botMay 7, 2013
D-217-2013Class IIIDerma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill DermaceuticalNovember 21, 2012
D-218-2013Class IIIDerma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLNovember 21, 2012
D-1646-2012Class IIIDerma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, May 8, 2012
D-1647-2012Class IIIDerma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28mL ), Rx only, FOR TOPICMay 8, 2012