FDAFDA · Food and drugs·Recall number D-1178-2014
ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20
Published April 2, 2014 · Recall initiated: January 31, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Brand
- DERMOTIC
- Manufacturer
- Hill Dermaceuticals, Inc.
- Distributor
- Nationwide and Puerto Rico
- Lot
- 13F015B exp. 12/14, 13G023B exp. 01/15
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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