Clinical Specialties announced a voluntary recall of Avastin (bevacizumab; Genentech) unit dose syringes after receiving reports of five intraocular infections from a physician’s office. Avastin was packaged in sterile syringes which were being used solely for an off-label indication by an ophthalmologist for macular degeneration.
The full list of affected product name and lot numbers can be found here. They were distributed to doctors’ offices in Georgia, Louisiana, South Carolina, and Indiana from December 18, 2012–present.
Avastin is an angiogenesis inhibitor currently approved for metastatic renal cell carcinoma (mRCC) in combination with interferon alfa; glioblastoma, as a single agent for patients with progressive disease following prior therapy; metastatic colorectal carcinoma, in combination with 5-FU-based chemotherapy for first- or second-line treatment, or in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine oxaliplatin-based therapy for second-line treatment in patients who have progressed on a first-line Avastin-containing regimen; and as first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC), in combination with carboplatin and paclitaxel.
Doctors that have the recalled Avastin product are recommended to stop using it immediately.
For more information call (866) 880-1915 or visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm344664.htm.