Reported Aug 22, 2012 · Terminated
Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR…
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) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT
- Manufactured and Distributed byHill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-149-04
- Lot codes and dates
- Lot Numbers-Scalp
- Oil
H100084 (exp 08/12)H100086 (08/12)J100093 (exp 08/12)J100094 (exp 09/12)J100097 (exp 09/12)K100101 (exp 09/12)K100103 (exp 10/12)K100104 (exp 10/12)K100108 (exp 10/12)K100112 (exp 10/12)L100860 (exp 11/12)L100890 (exp 11/12)L100910 (exp 11/12)
- Amount recalled
- 161,064 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Subpotent; fluocinolone acetonide
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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