Class III
Terminated
SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-507-04
- Company
- Hill Dermaceuticals, Inc.
- Recall Initiated
- January 31, 2014
- Posted
- April 2, 2014
- Recall Number
- D-1179-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4,142 bottles
- Firm Location
- Sanford, FL, United States
Reason for Recall
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
13F015C exp. 12/14.
More recalls by Hill Dermaceuticals, Inc.
DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by:...
Jun 30, 2021 · Class II
Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl. oz.) bottl...
Nov 27, 2013 · Class III
Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bot...
Jul 3, 2013 · Class III
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