Food and Drug Administration (FDA) issues recall for Brilliant Blue G; cases of fungal endophthalmitis reported

Recently, the FDA issued a MedWatch safety alert for four lots of Brilliant Blue G (BBG) ophthalmic solution that were dispensed from a pharmacy in Florida directly to ophthalmologists. The lots have been recalled because of reports of fungal endophthalmitis associated with the use of BBG in vitrectomy. According to the alert, the affected lot numbers are 08232011@80, 10132011@6, 10112011@82, and 10192011@125. Franck's Compounding, located in Ocala, Fla., stated that they notified 22 physicians who received BBG from a batch made in
August 2011 and began an immediate recall, and then subsequently
recalled supplies from an additional 78 physicians. The pharmacy suggests that healthcare practitioners adhere to pharmacy guidelines, use "single-use" vials as directed, and record patient, procedure, site, product lot, and product expiration date when using this product.
Any remaining BBG included in the recall lot numbers should be
returned to the pharmacy for credit by calling 352-622-2913.
Adverse events related to BBG should be communicated to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville,
Maryland 20852-9787.
Questions can be directed to Jenny Liljeberg, ASCRS•ASOA associate director of regulatory affairs, at jliljeberg@ascrs.org.