Alerts

Newsletter

Alert—Sterility of all Products from Franck’s Compounding Lab
May 4, 2012

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.

Newsletter

Alert Supplement—Franck’s Compounding Lab recalls sterile drugs
May 24, 2012

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.

Newsletter

Alert—KimVent® Closed Suction System (Adults) T-Piece
February 28, 2012

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).

The case

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