Safety

Avastin Unit Dose Syringes by Clinical Specialties: Recall - Potential For Serious Eye Infection

 

[Posted 03/20/2013]

AUDIENCE: Eye Care, Health Professional, Patient

ISSUE: 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.

BACKGROUND: This product was being used solely as an off label use by an ophthalmologist for macular degeneration and is packaged in sterile syringes (see Press Release for a list of lot numbers). This product would be administered by a licensed physician in a surgery or physician’s office setting and syringes were distributed to doctors’ offices in Georgia, Louisiana, South Carolina, and Indiana from December 18, 2012 to present.

RECOMMENDATION: 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.

[03/21/2013 - News Release - FDA]
[03/18/2013 - Press Release - Clinical Specialties]

 

Page Last Updated: 03/21/2013
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