Home / Recalls / Hill Dermaceuticals, Inc. / D-1646-2012

D-1646-2012 Class III Terminated

Recalled by Hill Dermaceuticals, Inc. — Sanford, FL

Recall Details

Product Type
Drugs
Report Date
August 22, 2012
Initiation Date
May 8, 2012
Termination Date
February 10, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
161,064 bottles

Product Description

Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-149-04

Reason for Recall

Subpotent; fluocinolone acetonide

Distribution Pattern

Nationwide

Code Information

Lot Numbers: -Scalp Oil: H100084 (exp 08/12), H100086 (08/12), J100093 (exp 08/12), J100094 (exp 09/12), J100097 (exp 09/12), K100101 (exp 09/12), K100103 (exp 10/12), K100104 (exp 10/12), K100108 (exp 10/12), K100112 (exp 10/12), L100860 (exp 11/12), L100890 (exp 11/12), L100910 (exp 11/12).

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-1178-2014 Class III — ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 (January 31, 2014)
  • D-1180-2014 Class III — SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl. (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-1176-2014 Class III — ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (January 31, 2014)
  • D-1177-2014 Class III — ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), (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-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)