For Immediate Release
September 6, 2016
ConsumersRugby®'s Customer Support Department
Livonia, MI - United Exchange Corp. of Cerritos, CA, a primary source vendor of the Rugby®-branded Eye Irrigating Solution and Major®-branded Eye Wash, is voluntarily recalling those lots and expiration dates described in the attached table due to microbial contamination. These products consist of a purified water solution.
Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight-threatening eye infection.
As part of its commitment to patient safety, 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 in the attached table.
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.
United Exchange Corp. is notifying its distributors and customers by recall letter and is arranging for return of all recalled products. Consumers, pharmacies, and healthcare facilities that have product which is being recalled should stop using and dispensing them immediately.
Consumers with questions regarding this recall should contact Rugby®'s Customer Support Department at 1-800-645-2158, available Monday through Friday 8a – 8p EST. Consumers can contact their physician or healthcare provider if they have additional questions about 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 regular mail or by fax:
• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre- addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the full knowledge of the U.S. Food and Drug Administration.
|Product Description||NDC Number||Lot Number||Expiration Date|
About Rugby® Laboratories
Rugby® Laboratories is a leading provider of high-quality Over the Counter, vitamin, and nutritional supplement products. With more than 40 years of history, Rugby® has been able to build out a comprehensive portfolio of products designed to enhance the quality of life for our consumers while reducing the cost of purchasing their medications.
About Major® Pharmaceuticals
For more than 30 years, Major® has been offering a broad and expanding portfolio of Rx unit dose, bulk and OTC options focused on supporting patient care efforts and providing economic value. Our product portfolio is positioned to simplify the ordering process, reduce reliance on multiple vendors and provide a comprehensive Rx and OTC formulary that can be used across your entire facility or healthcare system. The important outcome derived from this focus is in providing clinical, economic and operational value to our customers.