More Contaminated Eye Products From Florida Pharmacy

Emma Hitt, PhD

Disclosures

April 20, 2012

April 20, 2012 — The US Food and Drug Administration (FDA) has received additional reports of contamination in eye products supplied by Franck's Pharmacy in Ocala, Florida, this time in products containing triamcinolone.

The US Food and Drug Administration issued the safety alert regarding triamcinolone products from the MedWatch FDA Safety Information and Adverse Event Reporting Program.

Medscape Medical News initially wrote about a warning regarding Brilliant Blue G (BBG) on March 19.

In the earlier report, lots of Brilliant Blue G (BBG) ophthalmic solution, dispensed from Franck's directly to ophthalmologists, were reported to be contaminated with Fusarium species and caused fungal endophthalmitis.

Fusarium was cultured from select unused vials returned by physicians. At the time, the company noted that all of the remaining BBG from the August 2011 batch was accounted for and was no longer being used on patients.

In today's warning, the FDA noted that they have also recently received reports of eye infections in patients who were given injections of drug products containing triamcinolone, also supplied by Franck's Pharmacy, during eye surgery.

The Centers for Disease Control and Prevention has advised healthcare personnel to stop use of all sterile triamcinolone-containing products purchased from Franck's until further information regarding the safety of these products is available.

According to the FDA, adverse events were reported in several states, and these events are under investigation.

"FDA requests that practitioners report to FDA any cases of suspected fungal or bacterial infections, which have occurred within the last six months, associated with drugs labeled as sterile from Franck's Pharmacy," they write.

To date, Franck's has recalled all lots of BBG and 1 lot of Triamcinolone Acetonide PF.

Adverse events related to these or related products should be communicated to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

processing....