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 been recalled.
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.