Drug recall D-610-2013

Class III Terminated reported Jul 3, 2013

Product

Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA 32773; NDC 28105-149-04.

Reason for recall

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

Lots and codes

Lot #: H110940, Exp 08/13

Recall details

Recalling firm
Hill Dermaceuticals, Inc., Sanford, FL
Quantity
8,808 bottles
Distribution
Nationwide and Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
May 7, 2013
Terminated
July 19, 2013