From the American Academy of Ophthalmology

The Academy is alerting members of a voluntary nationwide recall of sterile, non-expired drugs including cyclosporine ophthalmic and triamcinolone acetonide. The drugs were compounded and distributed by Balanced Solutions Compounding Pharmacy in Lake Mary, Fla. The U.S. Food and Drug Administration said in a press release that the recall, which includes the two ophthalmic medications among a list of other medications, is due to a lack of sterility assurance and concerns with product quality controls. Poor practices and conditions, which may have exposed the company’s sterile products to microbial contamination, were observed during an FDA inspection, according to the release.

Customers with affected items should stop using the products immediately and return to Balanced Solutions. The pharmacy is contacting customers by phone, fax and/or mail with instructions to return the products to the pharmacy. Customers are also able to contact Balanced Solutions with questions at 407.936.2998 or 877.306.0008, or by email at pharmacist@bshrx.com.

Any adverse events or side effects related to Balanced Solution 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.