The FDA has announced a recall of all sterile ophthalmologic preparations shipped from Franck’s Compounding Lab since November 2011 because of the possibility of a fungal eye infection following use.
The recall first applied only to Brilliant Blue G, witch is an ophthalmologic dye manufactured by the lab for use during surgical procedures.
As of more recent, the recall has been expanded to include all preparations labeled sterile from the company following 33 cases of fungal eye infection in seven states after administration of Brilliant Blue G or products that contain triamcinolone from the compounding lab.
An FDA and CDC investigation of the situation is ongoing, according to an FDA statement. A separate statement from the company noted that the agency found samples of microorganisms and fungal growth in its clean room.
Field notes on the recall reported in Morbidity and Mortality Weekly Report showed the preparations were contaminated with bacterial and fungal contaminants, including F. incarnatum-equiseti species complex, Rhodotorula, Bullera, Pseudomonas, and Enterobacter species.[related_posts limit=”5″]