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U.S. Department of Health and Human Services

Safety

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Brilliant Blue G Compounded by Franck's: Recall of Unapproved Drug - Ongoing Investigation of Fungal Endophthalmitis Cases

 

[UPDATED 05/04/2012] The Centers for Disease Control and Prevention (CDC) has advised healthcare personnel to avoid use of compounded products labeled as sterile from Franck’s during the ongoing investigation. 

 

[UPDATED 04/20/2012] FDA issues second warning to physicians regarding certain compounded drugs from Franck's. FDA received reports of eye infections in patients who were given injections of drug products containing triamcinolone during eye surgery.

 

[Posted 03/19/2012]

AUDIENCE: Ophthalmology, Risk Manager

ISSUE: FDA has received reports of fungal endophthalmitis (eye infections) in patients who were given Brilliant Blue G (BBG), supplied by Franck's Pharmacy, 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 from Franck’s Compounding Lab. This includes all lots of Brilliant Blue G received from Franck’s.

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 from any source 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

 

[05/04/2012 - MMWR Weekly Report - CDC]

[05/04/2012 - Press Release - FDA]

[04/20/2012 - Related MedWatch Alert - FDA]

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

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