Policyholder Services

Drug Alert – The FDA Advises Ophthalmologists to Cease Use of Bevacizumab and Vancomycin from the Avella Specialty Pharmacy

Alert from the Academy:

The Academy is joining the U.S. Food and Drug Administration in alerting members to check their inventory and cease use of two medications produced by Avella Specialty Pharmacy due to concerns of sterility assurance with the pharmacy’s independent testing laboratory. Due to the concerns, Avella is recalling the following products:

Bevacizumab 1.25mg/0.05 mL PF, Lot Nos. 12-20130508@179, Expiry 11/3/201
Vancomycin PF (BSS) 1%, Lot Nos. 12-20130508@181, Expiry 10/4/2013

The FDA reports that Avella may have received inaccurate laboratory test results on the specified lot numbers, which has led to Avella voluntarily recalling the products out of an abundance of caution. To date, Avella has not received any reports of adverse events related to the recall.

Customers with affected items should discontinue use of the products and return the unused portion to Avella. The pharmacy is also notifying affected customers of the recall by phone and by mail. Further questions can be directed to Avella at 877.738.0797.

Any adverse events or side effects related to Avella products should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at:
Online at www.fda.gov/medwatch/report.htm