Reports of eye infections have been linked to drugs distributed by Franck’s Pharmacy, resulting in a recall for all medications compounded by the pharmacy.
A safety alert was posted on the FDA’s website on May 25, announcing the recall for all sterile human and veterinary prescriptions distributed by Franck’s Pharmacy, which is based in Ocala, Florida.
This action came after FDA investigators found microorganisms and fungal growth in environmental samples from the pharmacy’s clean room, suggesting that the medications may pose a risk of infection.
Investigations have linked reports of fungal eye infections to both the pharmacy’s Brilliant Blue G eye surgery compound, which was recalled in March, as well as intravitreal injections of triamcinolone products given during eye surgery.
According to a report issued earlier this month by the U.S. Centers for Disease Control and Prevention (CDC), there have been at least 33 confirmed or probable cases of fungal endophthalmitis in patients in seven states who underwent invasive eye surgery where Franck’s Pharmacy compounded drugs were used. Brilliant Blue G was linked to 20 of those cases, and triamcinolone products were linked to another 13.
Franck’s Pharmacy compounded drugs were distributed nationwide, and infections linked to the pharmacy’s products have been confirmed as far away as California.
Endophthalmitis is an eye infection that results in inflammation of the eye and can lead to vision loss and the loss of the entire eye in some cases. Antibiotics are usually applied via intravitreal injection (an injection into the eye itself), but in some cases eye removal is required.
The FDA moved to recall all of the company’s drugs after finding multiple bacterial and fungal species infesting unopened bottles and intact syringes from the pharmacy. The FDA then found fungal growth and bacteria in the pharmacy’s clean room. The recall affects all sterile products distributed by Franck’s Pharmacy since November 21, 2011.
The FDA is advising that no drugs be used from Franck’s Pharmacy that were made since November 2011.