FDA-Drug2014-04-02Class III
DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-160-20
Hill Dermaceuticals, Inc.
Hazard
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Sold states
Nationwide and Puerto Rico
Affected count
4,080 bottles
Manufactured in
2650 S Mellonville Ave, N/A, Sanford, FL, United States
Products
DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-160-20
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1173-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief