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

Tue, 03/19/2013 - 8:09am


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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