The U.S. Food & Drug Administration (FDA) has announced an urgent recall of Brilliant Blue G compounded at Franck’s Compounding Lab in Ocala, Florida. According to the recall notice, Brilliant Blue G has been associated with an unspecified fungal infection of the eye.
Brilliant Blue G is a dye used in eye surgery. On March 9, Franck’s Compounding Lab issued a letter to physicians informing them of the Brilliant Blue G recall. The letter asked doctors to immediately quarantine and return to the company any remaining Brilliant Blue G product they had in stock.
The FDA posted the company’s recall notice on its website today. According to the posting, the Brilliant Blue G recall involves all lots of the product. Lot numbers being recalled are:
According to the notice, the named lots of Brilliant Blue G are suspected of fungal contamination. The origin and cause of the eye infections has not yet been determined. The notice does not state how many eye infections are involved. The Brilliant Blue G recall has been issued as a “precautionary measure and to prevent any additional risk of eye infections in patients,” the notice states.
More information regarding the Brilliant Blue G recall can be obtained by contacting Franck’s Compounding Lab, Monday through Friday, 8 a.m. to 5 p.m., at 352-622-2913 ext. 209. Callers should request to speak to the Pharmacist-in-Charge.