Drug recall D-1178-2014
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
Reason for recall
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Lots and codes
13F015B exp. 12/14, 13G023B exp. 01/15
Recall details
- Recalling firm
- Hill Dermaceuticals, Inc., Sanford, FL
- Quantity
- 13,379 bottles
- Distribution
- Nationwide and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 31, 2014
- Terminated
- February 3, 2015
Related products
- Dermotic – drug information
- NDC 68791-103 Dermotic · Fluocinolone Acetonide .11 mg/mL · Royal Pharmaceuticals