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U.S. Department of Health and Human Services

Enforcement Report - Week of April 2, 2014

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Product Detail

Product Description ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20
Recall Number D-1178-2014
Classification Class III
Code Info 13F015B exp. 12/14, 13G023B exp. 01/15
Product Distributed Qty 13,379 bottles
Reason For Recall Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

Event Detail

Event Id 67420
Product Type Drugs
Status Ongoing
Recalling Firm Hill Dermaceuticals, Inc.
City Sanford
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-01-31
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide and Puerto Rico