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Date: Tue, 30 Aug 2005 From: ProMED-mail Source: FDA.gov [edited] ----------------------------------------------------------------- Nationwide recall of Trypan Blue 0.06 percent ophthalmic -------------------------------------------------------- Custom RX Compounding Pharmacy of Richfield, Minnesota, is initiating a nationwide recall of Trypan Blue 0.06 percent Ophthalmic Solution because it may be contaminated with _Pseudomonas aeruginosa_, a [type of] bacteria that, if applied to the eyes, might lead to serious injury, including possible blindness. Use of [the specific type of] Trypan Blue being recalled should stop immediately. --------------------------------------------------------------- Trypan Blue was distributed to hospitals and clinics in Maryland, Minnesota, Illinois, Nebraska, North Dakota, Michigan, District of Columbia, and Pennsylvania. This product is intended for ophthalmic use (in the eyes) during cataract surgery. FDA requires that all ophthalmic products be sterile. The solution is dark blue in appearance and is packaged in 1-cc sterile tuberculin syringes. Custom Rx Pharmacy is asking that all unexpired syringes be collected and returned to the pharmacy. The recall includes, but may not be limited to the following lot numbers: 05042005:86@17, 05252005:36@13, 06282005:91@27, 08012005:63@24, and 08182005:43@17. ______________________________________________________________--------------- The pharmacy has voluntarily recalled the products based on 2 reports of loss of vision possibly associated with use of the product as reported by CDC and a positive bacterial culture obtained at an outside hospital. Custom RX has verified the processes and technicians involved in the preparation of this medication. The pharmacy has been apprising the FDA of the recall efforts and is working [with] them on its investigation into the cause of the contamination. -------------------------------------------------------------- The pharmacy immediately began notifying customers and/or distributors and, working with the Centers for Disease Control (CDC), has called each individual hospital and clinic to arrange for the return, destruction, and reimbursement of all recalled product. ------------------------------------------------------------------- -- ProMED-mail [The contact person at CDC regarding reporting cases is Rebecca Sunenshine, MD, Phone (404) 639-4792 or Email . ______________________________________________________________-_______ Post-cataract bacterial endophthalmitis -- an infection of the anterior (aqueous humor) or posterior (vitreous humor) segments of the eye or both -- is a devastating complication of this eye surgery. It is a medical emergency, because delayed or inadequate therapy may lead to irreversible vision loss, and this may occur even with ideal therapy. The incidence has been 0.1 to 0.2 percent in several large series. ------------------------------------------------------------------ In most cases of post-cataract endophthalmitis, the source of the offending bacteria is the patient's own eyelid or conjunctival microflora. Coagulase- negative staphylococci are most common (about 70 percent); _Staphylococcus aureus_ causes about 9 percent; other Gram-positive cocci (both alpha- and beta- hemolytic streptococci) 5 percent; and Gram-negative bacilli 6 percent. - Mod.LL] -------------------------------------------------------------------- [see also: 2002 ---- Pseudomonas, mouth product contaminated - Norway 20020412.3936] ...................................ll/pg/jw *##########################################################* *