Reported Apr 3, 2013 · Terminated
Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL,…
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), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE, Net Contents 118.28 mL (4 fl. oz.), Hill Dermaceuticals, Inc., Sanford, Florida --- NDC 28105-149-04
- Lot codes and dates
Lot # D110550Exp. 04/2013
- Amount recalled
- 8,592 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; 22 month stability timepoint
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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