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Clinical Specialties Issues Voluntary Nationwide Recall of Avastin Unit Dose Syringes due to Potential Serious Eye Infection

 

Contact: Consumer: Austin Gore 866-880-1915  

FOR IMMEDIATE RELEASE -March 18 , 2013 - Clinical Specialties is voluntarily recalling Avastin unit dose syringes.

The product has or potentially could result in an infection within the eye. Clinical Specialties has received reports of five intra-ocular infections from physician’s office and this is how the problem was identified.

This product was being used solely as an off label use by an ophthalmologist for macular degeneration and is packaged in sterile syringes. The affected product name lots are as follows:

Lot Number		Exp. Date		Lot Number		Exp. Date
CABDAHAC:39		5/8/2013		CABDACAB:56		4/2/2013
CABDAGAC:58		4/13/2013		CABDACAB:76		4/2/2013
CABDAHAC:77		4/8/2013		CABDACAB:89		4/2/2013
CABDBIAC:86		4/19/2013		CABDADAB:69		4/3/2013
CABDCFAC:29		4/26/2013		CABDADAB:93		4/3/2013
CABDAEAD:26		5/3/2013		CABDADAB:54		4/3/2013
CABDAEAC:47		5/5/2013		CABDAEAB:96		4/4/2013
CABDAEAC:58		5/5/2013		CABDAHAB:00		4/7/2013
CABDAFAC:46		5/6/2013		CABDAHAB:59		4/7/2013
CABDAIAC:46		5/9/2013		CABDAHAB:18		4/7/2013
CABDBCAC:94		5/13/2013		CABDAJAB:30		4/9/2013
CABDCCAC:26		5/23/2013		CABDAJAB:70		4/9/2013
CABDCFAC:81		5/26/2013		CABDAJAB:97		4/9/2013
CABDABAD:05		5/30/2013		CABDBAAB:63		4/10/2013
CABDAFAC:47		5/6/2013		CABDBAAB:77		4/10/2013
CABDAGAC:43		5/7/2013		CABDBAAB:54		4/10/2013
CABDBDAC:69		5/14/2013		CABDBAAB:04		4/10/2013
CABDBIAC:77		5/19/2013		CABDBEAB:97		4/14/2013
CABDCHAC:19		5/28/2013		CABDBFAB:67		3/16/2013
CABDAHAD:21		6/5/2013		CABDBFAB:61		4/15/2013
CABDCFAC:17		5/26/2013		CABDBFAB:84		4/15/2013
CABDAHAD:00		6/5/2013		CABDBGAB:34		4/16/2013
CABDBCAC:47		5/13/2013		CABDBHAB:33		4/17/2013
CABDCBAC:97		5/22/2013		CABDBHAB:71		4/17/2013
CABDAGAC:08		5/7/2013		CABDBHAB:75		4/17/2013
CABDBCAC:15		5/13/2013		CABDCBAB:66		4/21/2013
CABDBDAC:17		5/14/2013		CABDCCAB:64		4/22/2013
CABDCIAC:42		5/29/2013		CABDCDAB:38		4/23/2013
CABDBEAC:44		5/15/2013		CABDCEAB:71		4/24/2013
CABDCBAC:79		5/22/2013		CABDCEAB:04		4/24/2013
CABDCIAC:00		5/29/2013		CABDCFAB:22		3/26/2013
CABDAHAD:82		6/5/2013		CABDCFAB:14		4/25/2013
CABDCBAC:31		5/22/2013		CABDCIAB:51		4/28/2013
CABDCIAB:68		4/28/2013		CABDCIAB:93		3/29/2013
CABDCJAB:59		4/29/2013		CABDDBAB:71		4/1/2013
CABDDBAB:93		5/1/2013		CABCBJBC:00		3/19/2013
CABCCGBC:92		2/24/2013		CABCCGBC:30		3/26/2013
CABCCGBC:49		3/26/2013		CABCCHBC:55		3/27/2013
CABCCIBC:39		3/23/2013		CABCDBBC:87		3/31/2013
CABCDBBC:71		3/1/2013

This product would be administered by a licensed physician in a surgery or physician’s office setting. The syringes were distributed to doctors’ offices in Georgia, Louisiana, South Carolina, and Indiana from December 18, 2012 to present.

Clinical Specialties has notified the physician’ offices by telephone. Doctors that have product which is being recalled should stop using the Avastin immediately.

Consumers with questions regarding this recall may contact Clinical Specialties by phone at 866.880.1915 or e-mail address at clinicalrx@bellsouth.net ; Monday through Friday between the hours of 10 am to 5 pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: www.fda.gov/medwatch/report.htm

Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Fax: 1-800-FDA-0178

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