FDA-Drug2014-04-02Class III
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. for: Royal Pharmaceuticals NDC 68791-101-04
Hill Dermaceuticals, Inc.
Hazard
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Sold states
Nationwide and Puerto Rico
Affected count
8,734 bottles
Manufactured in
2650 S Mellonville Ave, N/A, Sanford, FL, United States
Products
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. for: Royal Pharmaceuticals NDC 68791-101-04
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1176-2014Don't want to check this manually?
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