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

Date of Recall
2013-03-18

Recall Details
-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 [email protected] ; 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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