The U.S. Food and Drug Administration issued the following MedWatch announcement on August 29, 2005.
ATTENTION: the following notice refers ONLY to Trypan Blue 0.06% Ophthalmic Solution made by the Custom RX Compounding Pharmacy in Minnesota, NOT VisionBlue distributed by Dutch Ophthalmic, USA.
For more information on the recall, please contact Verne Betlach of the Custom RX Pharmacy at 612-866-2211, 612-810-1363 (mobile) for information.
From: MEDWATCH - The FDA Safety Information and Adverse Event Reporting Program on behalf of CDER MEDWATCH LISTSERV
Sent: Mon 8/29/2005 2:35 PM
To: MEDWATCH@LIST.NIH.GOV
Subject: FDA MedWatch - Trypan Blue 0.6% Ophthalmic Solution
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
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.
Read the complete MedWatch 2005 Safety summary, including a link to the firm's press release, at:
http://www.fda.gov/medwatch/safety/2005/safety05.htm#Trypan
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