Eye infections prompt bevacizumab recall

March 27, 2013

A Georgia compounding pharmacy has recalled 40 lots of injection syringes containing bevacizumab (Avastin, Genentech/Roche) after five patients developed intraocular infections.

 

Washington, DC-After receiving reports of five patients developing intraocular infections from off-label use of bevacizumab (Avastin, Genentech/Roche), a Georgia compounding pharmacy has been prompted to recall 40 lots of the injection syringes.

Clinical Specialties, of Martinez, GA, issued the voluntary nationwide recall of the unit dose syringes, which were distributed to physicians’ offices in Georgia, Indiana, Louisiana, and South Carolina from Dec. 18, 2012 to the present. The product has or potentially could result in an infection within the eye.

Bevacizumab is approved by the FDA for the treatment of various cancers and is frequently used off-label as a cost-effective therapy for age-related macular degeneration.

Physicians’ offices have been notified of the recall by the compounding pharmacy. The affected product name lots are posted on the FDA website.  Physicians with the product being recalled should discontinue use of the drug for their patients 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 10 a.m. and 5 p.m. EDT.

Consumers should contact their physician or health-care provider if they have experienced any problems that may be related to taking or using this 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.

For more articles in this issue of Ophthalmology Times eReport, click here.