FDA-Drug2013-07-03Class III
Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA 32773; NDC 28105-149-04.
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
8,808 bottles
Manufactured in
2650 S Mellonville Ave, Sanford, FL, United States
Products
Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA 32773; NDC 28105-149-04.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-610-2013Don't want to check this manually?
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