Brilliant Blue G Recalled Because of Fungal Contamination

Emma Hitt, PhD

March 19, 2012

March 19, 2012 — Four lots of Brilliant Blue G (BBG) ophthalmic solution that were dispensed from a pharmacy in Florida directly to ophthalmologists have been recalled because of reports of fungal endophthalmitis associated with the use of BBG in vitrectomy.

The US Food and Drug Administration on March 16 issued a safety alert from MedWatch, the FDA's safety information and adverse event reporting program.

According to the alert, the affected lot numbers are 08232011@80, 10132011@6, 10112011@82, and 10192011@125.

The pharmacy dispensing the solution, Franck's Compounding, located in Ocala, Florida, 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.

According to the pharmacy, Fusarium was cultured from select unused vials returned by physicians, although the source of the Fusarium has not been determined. According to the company, all of the remaining BBG from the August 2011 batch is accounted for and is no longer being used on patients.

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.

All lots of BBG received from Franck's Pharmacy 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, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.