Media:
Clinical Specialties
706-855-1915

FOR IMMEDIATE RELEASE – March 20, 2013 – Clinical Specialties is voluntarily recalling All Lots of All Sterile products repackaged and distributed by the pharmacy due to lack of sterility assurance.  The recall of all sterile products is conducted in follow-up to concerns regarding practices at the site which cannot assure the sterility of the products.  The expanded recall follows the firm’s initial recall of Avastin due to reports of five patients who have been diagnosed with serious eye infections associated with the use of the product.  Although there has been no evidence of contamination with sterile products other than the specified Avastin lots, Clinical Specialties has decided in the interest of their patients to proceed with this recall process.

The Center for Disease Control and Prevention (CDC) notified the FDA of these endophthalmitis infections, which occur inside the eyeball.  Endophthalmitis after intravitreal injection is a serious complication that can lead to permanent loss of vision.  Clinical Specialties Compounding repackaged the Avastin into individual single-use syringes from the manufactured vials labeled as sterile.

A compromised sterile product puts patients at risk for serious and possible life threatening infection.

Clinical Specialties Compounding sterile products covered under this recall were distributed nationwide between October 19, 2012 and March 19, 2013.  Until further notice, health care providers should stop using all sterile products distributed by Clinical Specialties Compounding and return them to the company.

Consumers or Health Care providers with questions regarding this recall may contact Clinical Specialties by phone at 866.880.1915 or e-mail address at This e-mail address is being protected from spambots. You need JavaScript enabled to view it ; Monday through Friday between the hours of 10 am to 5 pm EST.  Patients who have received any product distributed by Clinical Specialties Compounding and have concerns should contact their healthcare provider.

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.

Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

All Sterile Products

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