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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Custom-Rx Compounding Pharmacy Issues Nationwide Recall of Trypan Blue 0.06% Ophthalmic Solution

Contact:
Verne Betlach
612-866-2211

FOR IMMEDIATE RELEASE -- Richfield, MN -- August 26, 2005 -- Custom RX Compounding Pharmacy of Richfield, Minnesota, is initiating a nationwide recall of Trypan Blue 0.06% Ophthalmic Solution because it may be contaminated with Pseudomonas aeruginosa, a bacteria that, if applied to the eyes, might lead to serious injury, including possible blindness. Use of Trypan Blue which is being recalled should stop immediately.

Trypan Blue was distributed to hospitals and clinics in MD, MN, IL, NE, ND, MI, DC, and PA. 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 one 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 thefollowing 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 anda 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 Food & Drug Administration (FDA) of the recall efforts and is working 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.

For more information on the recall, please contact Verne Betlach with Custom RX Pharmacy at 612-866-2211, 612-810-1363 (mobile) for information.

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