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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Product Detail

Product Description Ophthalmic dilation gel, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Recall Number D-658-2013
Classification Class II
Code Info Lot number CABDBDAC:11, Exp date: 8/12/2013; Lot number CABCCHAJ:28, Exp date: 3/26/2013; Lot number CABCBBBA:57, Exp date: 4/9/2013; Lot number CABCCGBA:11, Exp date: 4/24/2013; Lot number CABCACBB:26, Exp date: 5/1/2013; Lot number CABCBGBB:54, Exp date: 5/15/2013; Lot number CABCCJBB:38, Exp date: 5/28/2013; Lot number CABCBDBC:40, Exp date: 6/11/2013; Lot number CABCCIBC:73, Exp date: 6/26/2013; Lot number CABDBBAB:32, Exp date: 7/10/2013; Lot number CABDCEAB:92, Exp date: 7/23/2013; Lot number CABDAHAC:76, Exp date: 8/6/2013; Lot number CABDCBAC:11, Exp date: 8/20/2013 and Lot number CABDAHAD:85, Exp date: 9/3/2013.
Product Distributed Qty 378ml total
Reason For Recall Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Event Detail

Event Id 64661
Product Type Drugs
Status Ongoing
Recalling Firm Clinical Specialties Compounding Pharmacy
City Augusta
State GA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-20
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern FL, GA and SC.