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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

Product Description Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy, Augusta, GA
Recall Number D-918-2013
Classification Class II
Code Info Lot #CABDAHAC:39, Exp. Date: 5/8/2013; Lot #CABDAGAC:58, Exp. Date: 4/13/2013; Lot #CABDAHAC:77, Exp. Date: 4/8/2013; Lot #CABDBIAC:86, Exp. Date: 4/19/2013; Lot #CABDCFAC:29, Exp. Date: 4/26/2013; Lot #CABDAEAD:26, Exp. Date: 5/3/2013; Lot #CABDAEAC:47, Exp. Date: 5/5/2013; Lot #CABDAEAC:58, Exp. Date: 5/5/2013; Lot #CABDAFAC:46, Exp. Date: 5/6/2013; Lot #CABDAIAC:46, Exp. Date: 5/9/2013; Lot #CABDBCAC:94, Exp. Date: 5/13/2013; Lot #CABDCCAC:26, Exp. Date: 5/23/2013; Lot #CABDCFAC:81, Exp. Date: 5/26/2013; Lot #CABDABAD:05, Exp. Date: 5/30/2013; Lot #CABDAFAC:47, Exp. Date: 5/6/2013; Lot #CABDAGAC:43, Exp. Date: 5/7/2013; Lot #CABDBDAC:69, Exp. Date: 5/14/2013; Lot #CABDBIAC:77, Exp. Date: 5/19/2013; Lot #CABDCHAC:19, Exp. Date: 5/28/2013; Lot #CABDAHAD:21, Exp. Date: 6/5/2013; Lot #CABDCFAC:17, Exp. Date: 5/26/2013; Lot #CABDAHAD:00, Exp. Date: 6/5/2013; Lot #CABDBCAC:47, Exp. Date: 5/13/2013; Lot #CABDCBAC:97, Exp. Date: 5/22/2013; Lot #CABDAGAC:08, Exp. Date: 5/7/2013; Lot #CABDBCAC:15, Exp. Date : 5/13/2013; Lot #CABDBDAC:17, Exp. Date: 5/14/2013; Lot #CABDCIAC:42, Exp. Date : 5/29/2013; Lot #CABDBEAC:44, Exp. Date: 5/15/2013; Lot #CABDCBAC:79, Exp. Date: 5/22/2013; Lot #CABDCIAC:00, Exp. Date : 5/29/2013; Lot #CABDAHAD:82, Exp. Date : 6/5/2013; Lot #CABDCBAC:31, Exp. Date: 5/22/2013; Lot #CABDCIAB:68, Exp. Date: 4/28/2013; Lot #CABDCJAB:59, Exp. Date: 4/29/2013; Lot #CABDDBAB:93, Exp. Date: 5/1/2013; Lot #CABCCGBC:92, Exp. Date: 2/24/2013; Lot #CABCCGBC:49, Exp. Date: 3/26/2013; Lot #CABCCIBC:39, Exp. Date: 3/23/2013; Lot #CABCDBBC:71, Exp. Date: 3/1/2013; Lot #CABDACAB:56, Exp. Date: 4/2/2013; Lot #CABDACAB:76, Exp. Date: 4/2/2013; Lot #CABDACAB:89, Exp. Date: 4/2/2013; Lot #CABDADAB:69, Exp. Date: 4/3/2013; Lot #CABDADAB:93, Exp. Date: 4/3/2013; Lot #CABDADAB:54, Exp. Date: 4/3/2013; Lot #CABDAEAB:96, Exp. Date: 4/4/2013; Lot #CABDAHAB:00, Exp. Date: 4/7/2013; Lot #CABDAHAB:59, Exp. Date: 4/7/2013; Lot #CABDAHAB:18, Exp. Date: 4/7/2013; Lot #CABDAJAB:30, Exp. Date: 4/9/2013; Lot #CABDAJAB:70, Exp. Date: 4/9/2013; Lot #CABDAJAB:97, Exp. Date: 4/9/2013; Lot #CABDBAAB:63, Exp. Date: 4/10/2013; Lot #CABDBAAB:77, Exp. Date: 4/10/2013; Lot #CABDBAAB:54, Exp. Date: 4/10/2013; Lot #CABDBAAB:04, Exp. Date: 4/10/2013; Lot #CABDBEAB:97, Exp. Date: 4/14/2013; Lot #CABDBFAB:67, Exp. Date: 3/16/2013; Lot #CABDBFAB:61, Exp. Date: 4/15/2013; Lot #CABDBFAB:84, Exp. Date: 4/15/2013; Lot #CABDBGAB:34, Exp. Date: 4/16/2013; Lot #CABDBHAB:33, Exp. Date: 4/17/2013; Lot #CABDBHAB:71, Exp. Date: 4/17/2013; Lot #CABDBHAB:75, Exp. Date: 4/17/2013; Lot #CABDCBAB:66, Exp. Date: 4/21/2013; Lot #CABDCCAB:64, Exp. Date: 4/22/2013; Lot #CABDCDAB:38, Exp. Date: 4/23/2013; Lot #CABDCEAB:71, Exp. Date: 4/24/2013; Lot #CABDCEAB:04, Exp. Date: 4/24/2013; Lot #CABDCFAB:22, Exp. Date: 3/26/2013; Lot #CABDCFAB:14, Exp. Date: 4/25/2013; Lot #CABDCIAB:51, Exp. Date: 4/28/2013; Lot #CABDCIAB:93, Exp. Date: 3/29/2013; Lot #CABDDBAB:71, Exp. Date: 4/1/2013; Lot #CABCBJBC:00, Exp. Date: 3/19/2013; Lot #CABCCGBC:30, Exp. Date: 3/26/2013; Lot #CABCCHBC:55, Exp. Date: 3/27/2013 and Lot #CABCDBBC:87, Exp. Date: 3/31/2013
Product Distributed Qty 2190 syringes
Reason For Recall Lack of Assurance of Sterility; product linked to adverse event reports of endophthalimitis eye infections and FDA inspection findings resulted in concerns regarding quality control processes

Event Detail

Event Id 65253
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 2013-03-11
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern FL, GA, IN, LA and SC.
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