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U.S. Department of Health and Human Services

Safety

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Trypan Blue 0.06% Ophthalmic Solution

Audience: Ophthalmologists, other healthcare professionals, and consumers

[Posted 08/29/2005] Custom RX Compounding Pharmacy and FDA notified ophthalmologists, other healthcare professionals, and consumers about a nationwide recall of Trypan Blue 0.06% Ophthalmic Solution, intended for use in the eyes during cataract surgery, because it may be contaminated with Pseudomonas aeruginosa, a bacteria that, if applied to the eyes, might lead to serious injury, including possible blindness. Custom Rx Pharmacy is asking that all unexpired syringes be collected and returned to the pharmacy. The product was distributed to hospitals and clinics in Maryland, Minnesota, Illinois, Nebraska, North Dakota, Michigan, the 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.

[August 26, 2005 - Press Release - FDA]