FDA MedWatch - Eye Wash/Eye Irrigating Solutions Distributed by Major Pharmaceuticals and Rugby Laboratories: Recall - Microbial Contamination

"FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Wed, 07 Sep 2016 19:50:09 -0500

Title:     FDA MedWatch - Eye Wash/Eye Irrigating Solutions Distributed by Major Pharmaceuticals and Rugby Laboratories: Recall - Microbial Contamination

  Eye Wash/Eye Irrigating Solutions Distributed by Major Pharmaceuticals and Rugby Laboratories: Recall - Microbial Contamination
AUDIENCE: Consumers, Eye Care, Pharmacy
ISSUE: 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 products 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.
BACKGROUND: 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. For a table of affected lots and expiration dates please see firm press release. 
RECOMMENDATION: Consumers, pharmacies, and healthcare facilities that have product which is being recalled should stop using and dispensing them immediately.
Healthcare professionals and consumers may report adverse reactions or quality problems they experienced using these devices to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form 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.

Read the MedWatch Safety Alert, including a link to the Firm Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm519570.htm

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