Home / Recalls / Hill Dermaceuticals, Inc. / D-007-2014

D-007-2014 Class III Terminated

Recalled by Hill Dermaceuticals, Inc. — Sanford, FL

Recall Details

Product Type
Drugs
Report Date
November 27, 2013
Initiation Date
September 8, 2013
Termination Date
August 4, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Scalp Oil), 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-149-04.

Reason for Recall

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

Distribution Pattern

Nationwide and Puerto Rico.

Code Information

K111090 exp.10/13, K111122 exp10/13, K111140 exp.10/13, K111150 exp.10/13, 111180 exp.11/13, L111190 exp11/13, M111250 exp.12/13, M111270 exp.12/13, and M111292 exp.12/13

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-1178-2014 Class III — ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 (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)
  • D-1173-2014 Class III — DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Ma (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-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)