From the American Academy of Ophthalmology

The Academy is joining the U.S. Food and Drug Administration in alerting members to check their inventory and cease use of sterile products supplied by Specialty Compounding in Cedar Park, Texas. Pharmacy officials have confirmed to the Academy that they supply sterile products to ophthalmologists and ophthalmic ambulatory surgery centers.

The FDA reports that bacterial infections have been potentially associated with contaminated calcium gluconate infusions produced by the pharmacy.
The agency has received reports of 15 adverse events experienced by patients in two hospitals. The agency is working with the Centers for Disease Control and Prevention and Texas state officials to investigate the cause of these bacterial infections.

Customers with affected items should stop using the products immediately. Any adverse events or side effects related to Specialty Compounding products should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Online at www.fda.gov/MedWatch/report.htm; or
• Download or call 800.332.1088 to request a reporting form. Return the form to the address provided therein or fax to 800.332.0178.

For more information, contact the Academy’s Governmental Affairs Division at 202.737.6662.