FDAClass IISeptember 4, 2013

Avastin recall: Sterility Concern

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

Why was Avastin 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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
Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy, Augusta, GA
Recalling firm
Clinical Specialties Compounding Pharmacy
Quantity
2190 syringes
Distribution
FL, GA, IN, LA and SC.
Recall date
September 4, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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