A recent influx of adverse events has been linked to the use certain stains implemented by retinal surgeons. Subsequently, the U.S. 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. Furthermore, BBG is not an approved drug in the United States, serving to only complicate the already ambiguous situation. Due to such extenuated circumstances, the FDA has issued a recall of all lots of BBG that have been procured from Franck’s Pharmacy.
Commonly used in the medical field, Brilliant Blue G is used as a stain to assist surgeons in retinal surgery. The blue pigment helps medical professionals to identify and determine critical aspects of the surgical procedure. However, recent reports suggest that the use of BBG may be responsible for catastrophic complications.
It has recently come to the attention of the FDA, that specific lots of Brilliant Blue G released by Franck’s Pharmacy may be responsible for the development of severe eye infections. Endophthalmitis refers to intraocular inflammation involving the vitreous and anterior chamber of the eye. In most cases, endophthalmitis results from an infectious organism. However, recent reports suggest that BBG may serve as a catalyst for such an infection. Fungal endophthalmitis can be divided into the less common endogenous infections and the more common exogenous infections. It is not uncommon for an infection of this nature to cause severe vision complications.
While the origin and cause of these infections have yet to be determined, the following lots of Brilliant Blue G are suspected of fungal contamination:
Lot Number:
- 08232011@80
- 10132011@6
- 10112011@82
- 10192011@125
As a precautionary measure and to prevent any additional risk of eye infections in patients, Franck has recalled all Brilliant Blue G compounds produced in their labs. Establishments have already been ordered to quarantine and return any remaining Brilliant Blue G product they may currently have. The BBG recall includes all lots of Brilliant Blue G that have been distributed from Franck’s Compounding Lab, Ocala, Florida.
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