There is a reasonable probability of a potentially sight-threatening eye infection through the use of a contaminated eye wash or irrigating solution product.
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 table below. (NOTE: This recall has also expanded to include Family Care products. See: Recall Extends to Family Care Brand Eye Wash.)
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| Product Description | NDC Number | Lot Number | Expiration Date |
|---|---|---|---|
| Major EyeWash | 0904-6491-20 | G15905 | 2018.10 |
| Major EyeWash | 0904-6491-20 | G15906 | 2018.10 |
| Major EyeWash | 0904-6491-20 | G15907 | 2018.10 |
| Major EyeWash | 0904-6491-20 | G15910 | 2018.11 |
| Major EyeWash | 0904-6491-20 | G15911 | 2018.11 |
| Major EyeWash | 0904-6491-20 | G15912 | 2018.11 |
| Major EyeWash | 0904-6491-20 | G16901 | 2019.01 |
| Major EyeWash | 0904-6491-20 | G16902 | 2019.01 |
| Major EyeWash | 0904-6491-20 | G16903 | 2019.01 |
| Major EyeWash | 0904-6491-20 | G16905 | 2019.02 |
| Major EyeWash | 0904-6491-20 | G16906 | 2019.02 |
| Major EyeWash | 0904-6491-20 | G16907 | 2019.02 |
| Major EyeWash | 0904-6491-20 | G16910 | 2019.03 |
| Major EyeWash | 0904-6491-20 | G16911 | 2019.03 |
| Rugby EyeWash | 0536-1083-97 | G15908 | 2018.10 |
| Rugby EyeWash | 0536-1083-97 | G15909 | 2018.11 |
| Rugby EyeWash | 0536-1083-97 | G16904 | 2019.01 |
| Rugby EyeWash | 0536-1083-97 | G16908 | 2019.02 |
| Rugby EyeWash | 0536-1083-97 | G16912 | 2019.03 |
| Rugby EyeWash | 0536-1083-97 | G16913 | 2019.03 |
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.
Product/Package Photos
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.
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This recall is being conducted with the full knowledge of the U.S. Food and Drug Administration.
Source: FDA
