Home / Recalls / Hill Dermaceuticals, Inc. / D-1178-2014

D-1178-2014 Class III Terminated

Recalled by Hill Dermaceuticals, Inc. — Sanford, FL

Recall Details

Product Type
Drugs
Report Date
April 2, 2014
Initiation Date
January 31, 2014
Termination Date
February 3, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,379 bottles

Product Description

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

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

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

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-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)
  • 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-007-2014 Class III — Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Scalp Oil), 118.28 (September 8, 2013)