FDA recalls Brilliant Blue G

March 28, 2012

The FDA has recalled Brilliant Blue G compounded by Franck's Labs Inc. of Ocala, FL, after receiving reports of fungal endophthalmitis. The ophthalmic solution is an unapproved drug used during eye surgeries.

Silver Spring, MD-The FDA has recalled Brilliant Blue G compounded by Franck’s Labs Inc. of Ocala, FL, after receiving reports of fungal endophthalmitis. The ophthalmic solution is an unapproved drug used during eye surgeries.

Clinicians in several states reported the adverse events, which are being investigated by the FDA, the Centers for Disease Control and Prevention, and local and state public health agencies. Lots with suspected contamination, according to the compounding lab, include 08232011@80, 10132011@6, 10112011@82, and 10192011@125.

Ophthalmologists who possess the solution from any lot should immediately quarantine it and return it to where they purchased it. Franck’s is issuing credits for returned products purchased there.

Franck’s customers who would like additional information may call the pharmacy weekdays from 8 a.m. to 5 p.m. at 352/622-2913, ext. 209, and request to speak with the pharmacist-in-charge.

Also, the FDA is asking practitioners to report to the agency’s MedWatch Safety Information and Adverse Event Reporting Program any cases of fungal or bacterial endophthalmitis that have occurred within the past 6 months and are associated with eye surgery in which Brilliant Blue G from any source was used. Healthcare professionals and patients can download a reporting form online at www.fda.gov/MedWatch/report.htm or call 800/332-1088 to request a form. Completed forms can be returned to the address on the form or can be submitted via fax to 800/332-0178.

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