Reported Nov 27, 2013 · Terminated
Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 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) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl. oz.) bottle, Rx only
- Manufactured and Distributed byHill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-150-04
- Lot codes and dates
K111100 exp.10/13K111110 exp.10/13M111240 exp.12/13and A120012 exp.01/14
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
- 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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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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