Class III
Terminated
Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-150-04.
- Company
- Hill Dermaceuticals, Inc.
- Recall Initiated
- September 8, 2013
- Posted
- November 27, 2013
- Recall Number
- D-008-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- 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
K111100 exp.10/13, K111110 exp.10/13, M111240 exp.12/13, and A120012 exp.01/14
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Jul 3, 2013 · Class III
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