Franck’s Brilliant Blue G Recalled For Unofficial Drug: Analysis Of Fungal Endopthalmitis Underway

There have been established cases of eye infections (fungal endopthalmitis) associated with the use of Franck’s Brilliant Blue G; and risk assessment managers, ophthalmologists, and other eye specialists have been called to take note of the recalled product.

Francks Pharmacy Compounding Lab

Background of Brilliant Blue G by Franck’s

Brilliant Blue G (BBG) is a product that’s compounded by Franck’s Compounding Lab in Ocala, Florida and below are some of the facts about the product:

• BBG (Brilliant Blue G) is not an FDA-approved medical drug in the United States
• It is a medical product labeled for ophthalmic uses such as during eye surgery

FDA Alert on Franck’s Brilliant Blue G

There have been reported cases of eye infections or fungal endopthalmitis, in connection to the use of BBG, Brilliant Blue G from Franck’s.

Reported cases were particularly highlighted in eye patients on whom BBG was used during their eye surgeries.

The side effects and adverse events linked to the use of Franck’s Brilliant Blue G are currently under ongoing analyses and investigations by the following authorities:

• the FDA (Food and Drug Administration)
• the CDC (Centers for Disease Control and Prevention)
• state health agencies
• local health agencies

The manufacturing pharmacy responsible for compounding BBG, Franck’s Lab, issued the recall announcement on 9^th Mar, 2012, further highlighting details of the product batches affected by the recall. These details are as follows:

• Lot Number – 10192011; No. of Lots – 125
• Lot Number – 10132011; No. of Lots – 6
• Lot Number – 10112011; No. of Lots – 82
• Lot Number – 08232011; No. of Lots – 80

All the above listed lots of Franck’s Brilliant Blue G were indicated to have been affected with the presence of fungal contagions.

FDA Recommendation on Franck’s Brilliant Blue G

“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.”

Contacting the FDA to report cases related to Brilliant Blue G

Any adverse side effects or incidences relating to the use of Brilliant Blue G (which is compounded by Franck’s Compounding Lab) should immediately be reported to the FDA.

This should be done by contacting or informing the FDA’s MedWatch Safety Information & Adverse Event Reporting Program through any of the following ways:

• Filling and submitting an online report at: http://www.fda.gov/MedWatch/report.htm
• Download the case reporting form at:http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm
• Dialing 1-800-332-1088 and requesting to get a report form, filling it and returning it to the address indicated on the form
• Faxing the filled-up form to the fax number: 1-800-FDA-0178

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