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
