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FDA Recalls Brilliant Blue G due to Reports of Severe Eye Infections

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Washington, DC: The Centers for Disease Control and Prevention (CDC) is advising healthcare personnel to avoid use of compounded products labeled as sterile from Franck' while an investigation by the Food and Drug Administration (FDA) is underway.

The FDA has issued a second warning to physicians regarding certain compounded drugs from Franck's. The FDA received reports of eye infections in patients who were given injections of drug products containing triamcinolone during eye surgery.

The BBG was supplied by Franck' Compounding Lab, Ocala, Florida. Franck' Pharmacy issued a recall on March 9, 2012, of all lots of Brilliant Blue G and issued a recall letter. Brilliant Blue G is not an approved drug in the U.S. The Food and Drug Administration (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 Centers for Disease Control (CDC) and local and state public health agencies, are actively investigating these adverse events.

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Last updated May 4 2012

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