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Author ------ Message
 Author: crow
PostPosted: Wed Sep 07, 2016 6:22 pm 
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: http://www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form http://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 Descript 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

# # #
Rugby®'s Customer Support Department

 Author: crow
PostPosted: Thu Sep 08, 2016 8:42 am 
This Recall has been expanded to include the following lots of Family Care Eye Wash 4 oz due to microbial contamination. These products consist of a purified water solution.
Lot# - Expiration - UPC Number
G15901- 07/31/2018- 780707005828
G15902- 07/31/2018- 780707005828
G15903- 07/31/2018- 780707005828
G15904- 07/31/2018- 780707005828
G16909- 05/30/2019- 780707005828

http://www.fda.gov/Safety/Recalls/ucm51 ... ovdelivery

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