Recalls / Class II

Class IID-918-2013

Product

Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy, Augusta, GA

Affected lot / 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

Why it was recalled

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

Recalling firm

Firm

Clinical Specialties Compounding Pharmacy

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

318 Baston Rd, Augusta, Georgia 30907

Distribution

Quantity

2190 syringes

Distribution pattern

FL, GA, IN, LA and SC.

Timeline

Recall initiated

2013-03-11

FDA classified

2013-08-23

Posted by FDA

2013-09-04

Terminated

2017-02-22

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-918-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.