Reported Apr 2, 2014 · Terminated
DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured and Distributed by: Hill…
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?
- DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle
- Rx only Manufactured and Distributed byHill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-160-20
- Lot codes and dates
- 12H028B exp. 01/14
- Amount recalled
- 4,080 bottles
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are 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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