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.
Reported: November 27, 2013 Initiated: September 8, 2013 #D-008-2014
Product Description
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.
Reason for Recall
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Details
- Recalling Firm
- Hill Dermaceuticals, Inc.
- Distribution
- Nationwide and Puerto Rico.
- Location
- Sanford, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Hill Dermaceuticals, Inc..
Why was this product recalled? ▼
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 27, 2013. Severity: Low. Recall number: D-008-2014.
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