drugs Class III Updated 2014-04-02

Hill Dermaceuticals, Inc. recalls ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.

Recalled Product

ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20

Hazard / Issue

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 13F015B exp. 12/14, 13G023B exp. 01/15
View official government recall

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