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07-06-2013, 01:58 AM #1
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- Aug 2012
- Merced, CA 95348-1422
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Recall: Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %
Product Description 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.
Recall Number D-610-2013
Classification Class III
Code Info Lot #: H110940, Exp 08/13
Product Distributed Qty 8,808 bottles
Reason For Recall Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Event Id 65434
Product Type Drugs
Hill Dermaceuticals, Inc.
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-07
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico