Drug Enforcement D-918-2013

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

Status

Terminated

Classification

Class II

Report Date

September 4, 2013

Termination Date

February 22, 2017

Product Information

Product description
Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy, Augusta, GA
Product quantity
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
Recall initiation reason
—
Initial firm notification
Telephone
Distribution pattern
FL, GA, IN, LA and SC.

Location & Firm

Recalling firm
Clinical Specialties Compounding Pharmacy
Address
318 Baston Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-918-2013
Event ID
65253
Recall initiation date
March 11, 2013
Center classification date
August 23, 2013
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
More code info
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