Brilliant Blue G: Recall of Unapproved Drug - Ongoing Investigation of Fungal Endophthalmitis Cases

March 19, 2012

Audience: Ophthalmology, Risk Manager

ISSUE: FDA has received reports of fungal endophthalmitis (eye infections) in patients who were given Brilliant Blue G (BBG) during eye surgeries. Clinicians in several states reported the adverse events. FDA, along with CDC and local and state public health agencies, are actively investigating these adverse events.

BACKGROUND: The BBG was supplied by Franck’s Compounding Lab, Ocala, Florida. Franck’s Pharmacy issued a recall on March 9, 2012, of all lots of Brilliant Blue G and issued a recall letter (link below). Brilliant Blue G is not an approved drug in the U.S. 

RECOMMENDATION: Immediately quarantine and return any remaining Brilliant Blue G product. This includes all lots of Brilliant Blue G received from Franck’s Pharmacy.

FDA requests that practitioners report to MedWatch any cases of endophthalmitis, fungal or bacterial, that occurred within the last six months, associated with eye surgery in which Brilliant Blue G was used.


Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[03/19/2012 - Warning Statement - FDA]
[03/09/2012 - Recall Letter - Franck’s Pharmacy] 

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