ST. GEORGE – A voluntary recall has been issued for three brands of eyewash due to microbial contamination. Consumers are urged to stop using the products immediately.
United Exchange Corp. of Cerritos, California, is recalling Family Care Eye Wash, Major EyeWash and Rugby Eye Irrigating 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,” a company statement said.
Rugby Laboratories and Major Pharmaceuticals are working with United Exchange to notify customers who may have purchased Rugby Eye Irrigating Solution NDC 0536-1083-97 or Major Eye Wash NDC 0904-6491-20.
The eye wash and eye irrigation solutions are used to rinse foreign material such as air pollutants or chlorinated water from the eyes.
The eye wash solutions, in 4-ounce or 118-millimeter containers, were distributed nationwide to wholesale and retail facilities including hospitals and pharmacies.
United Exchange learned of the issue from a product complaint and is notifying its distributors and customers by recall letter and is arranging for the return of all recalled products.
Consumers, pharmacies, and healthcare facilities should stop using or dispensing the products immediately.
Consumers with questions regarding this recall should contact Rugby’s customer support department at 1-800-645-2158 Monday through Friday from 8 a.m. to 8 p.m. Eastern Standard Time.
Consumers should contact their physician or healthcare provider if they have additional questions about this product.
Affected lots and expiration dates of Major and Rugby eye wash
|Product Description||NDC Number||Lot Number||Expiration Date|
Affected lots and expiration dates of Family Care eye wash
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by 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. Reports can also be submitted by fax to 1-800-FDA-0178.
Email: [email protected]
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