Drug recall D-1176-2014

Class III Terminated reported Apr 2, 2014

Product

ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. for: Royal Pharmaceuticals NDC 68791-101-04

Reason for recall

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

Lots and codes

13E013A exp. 11/14.

Recall details

Recalling firm
Hill Dermaceuticals, Inc., Sanford, FL
Quantity
8,734 bottles
Distribution
Nationwide and Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
January 31, 2014
Terminated
February 3, 2015

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