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.

The investigation expanded when additional cases of fungal endophthalmitis were discovered associated with intravitreal injection of triamcinolone-containing products from the same pharmacy. 33 cases have been identified so far: 20 associated with BBG and 13 with triamcinolone. The BBG patients were infected with Fusarium incarnatum-equiseti, and the triamcinolone patients with Bipolaris hawaiiensis.

Today, May 4, the Centers for Disease Control (CDC) published notes from their ongoing investigation (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6117a5.htm for further details). As part of their investigation, they found that unopened bottles of BBG from Franck’s contained multiple bacteria and fungi, including F. incarnatum-equiseti species complex, Rhodotorula, Bullera, Pseudomonas, and Enterobacter.

To date, all BBG dye lots, and one lot of triamcinolone from Franck’s have been recalled in cooperation with the FDA, but other products have not. Franck’s compounds a number of other products, including sterile drugs for intrathecal, epidural, ophthalmic, intravenous, inhalation and intranasal administration.

Because of the risks involved (77% of the affected patients so far have had some vision loss), and the ongoing state of the investigation into the sterility of products from this supplier, the CDC recommends that, “at this time, clinicians avoid use of compounded products labeled as sterile from Franck’s” and should have a heightened suspicion for bacterial or fungal infections in patients who have received products labeled as sterile from this pharmacy.

Commands