FDA Announces Recall of Eye Wash/Eye Irrigating Solutions Distributed by Major Pharmaceuticals and Rugby Laboratories Due to Microbial Contamination

The Food and Drug Administration (FDA) has announced that United Exchange Corp. of Cerritos, Calif., a primary source vendor of the Rugby®-branded Eye Irrigating Solution and Major®-branded Eye Wash, is voluntarily recalling certain lots due to microbial contamination. These products consist of a purified water solution.

ASCRS•ASOA is notifying its members of the potential to see patients who may have been affected by the contaminated product since there is a reasonable probability of a potentially sight-threatening eye infection.

A full list of the affected lots of the product are available on the FDA’s website.

Rugby® Laboratories and Major® Pharmaceuticals are working with United Exchange Corp. to notify customers who may be in possession of either Rugby Eye Irrigating Solution NDC 0536-1083-97 or Major Eye Wash NDC 0904-6491-20 for those lots and expiration dates listed on the FDA website.

Eye Wash/Eye Irrigating Solution is used to flush the eye to relieve irritation, stinging, or itching by removing foreign material such as air pollutants or chlorinated water. It is packaged in 4-oz. (118mL) bottles. Rugby®-branded Eye Irrigating Solution and Major®-branded Eye Wash were distributed nationwide to wholesale and retail facilities, including hospitals and pharmacies. The company learned of the potential issue through the receipt of a product complaint regarding this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by U.S. mail, or by fax:

If you have additional questions, please contact Allison Madson, manager of regulatory affairs, at amadson@ascrs.org or 703-591-2220.