Custom RX initiates voluntary recall of trypan blue

September 6, 2005

Custom RX Compounding Pharmacy, of Richfield, MN, said it initiated a nationwide recall of trypan blue 0.06% ophthalmic solution, which may be contaminated with Pseudomonas aeruginosa. Use of trypan blue should stop immediately; if applied to eyes, the bacteria could cause serious injury, even blindness, the pharmacy said in a prepared statement posted on the FDA’s Web site.

Custom RX Compounding Pharmacy, of Richfield, MN, said it initiated a nationwide recall of trypan blue 0.06% ophthalmic solution, which may be contaminated with Pseudomonas aeruginosa. Use of trypan blue should stop immediately; if applied to eyes, the bacteria could cause serious injury, even blindness, the pharmacy said in a prepared statement posted on the FDA’s Web site.

Trypan blue, which is packaged in 1-ml sterile tuberculin syringes, was distributed in hospitals and clinics in Maryland, Minnesota, Illinois, Nebraska, North Dakota, Michigan, District of Columbia, and Pennsylvania. 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.

Custom RX Compounding Pharmacy is asking that all unexpired syringes be collected and returned to the pharmacy. The pharmacy said it voluntarily recalled the products based on two reports of loss of vision possibly associated with use of the product as reported by the Centers for Disease Control and Prevention and a positive bacterial culture obtained at an outside hospital.

For more details, ophthalmic professionals are asked to contact the pharmacy at 612/866-2211.