An outbreak of fungal endophthalmitis, first identified in
California, has raised concerns about the sterility of products
from Franck’s Compounding Lab: a Florida compounding pharmacy.
This cluster of cases was in patients who had undergone
vitrectomy with epiretinal membrane peeling using a dye called
Brilliant Blue-G (BBG). All lots of BBG produced by Franck’s have
Franck’s Compounding Lab today issued a recall of all sterile
human and veterinary compounded prescriptions dated November 21,
2011, and later. The notice states that “it is essential that you
do not use them and that employing appropriate practices, you
destroy all such sterile preparations and all remaining portions
of such sterile preparations.” This recall resulted from the
FDA’s discovery of microorganisms and fungal growth in Franck’s
clean room.The recall notice is posted at www.francks.com.
The cap needs to be removed for safe use in patients receiving
continuous flow therapy.
CHPSO periodically reviews California Department of Public Health
(CDPH) citations for opportunities to improve patient safety and
prevent future events.In reviewing the following event, CHPSO
identified a recurrent issue (as evidenced by reports in the FDA
device event database).
Interested counsel may join a discussion group that offers
support and an opportunity to learn about the new legal
privileges and challenges of the Patient Safety and Quality
Improvement Act of 2005. You can request to join the
group by following this link: eepurl.com/rKJaf. This group
generally holds conference calls quarterly.