Avastin Unit Dose Syringes Clinical Specialties Recall

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

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 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.

Read the MedWatch safety alert, including a link to the Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm344664.htm

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