Reported Jul 3, 2013 · Terminated
Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only,…
Hill Dermaceuticals, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hill Dermaceuticals, Inc. · 2650 S Mellonville Ave · Sanford, FL · 32773-9311
Is this the product you have?
- Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only
- Manufactured and Distributed byHill Dermaceuticals, Inc. SANFORD, FLORIDA 32773; NDC 28105-149-04
- Lot codes and dates
Lot #: H110940Exp 08/13
- Amount recalled
- 8,808 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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