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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 Cyclosporine 1% ophthalmic drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Recall Number D-636-2013
Classification Class II
Code Info Lot number CABCBEBB:35, Exp date: 5/13/2013; Lot number CABACAB:76 Exp date: 7/1/2013; Lot number CABDAIAB:78, Exp date: 4/8/2013; Lot number CABDAEAC:80, Exp date: 5/5/2013 and Lot number CABDCCAC:31, Exp date: 5/23/2013.
Product Distributed Qty 55 ml
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.