FDA MedWatch - Family Care Eye Wash by United Exchange Corp: Recall - Microbial Contamination

["FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - Family Care Eye Wash by United Exchange Corp: Recall - Microbial Contamination

Family Care Eye Wash by United Exchange Corp: Recall - Microbial Contamination

AUDIENCE: Consumers, Eye Care, Pharmacy

ISSUE:  United Exchange Corp. is voluntarily recalling specific lots of Family Care Eye Wash 4 oz 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.

See the Press Release for a list of affected Lot numbers.

BACKGROUND: Eye Wash/Eye Irrigation 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. Family Care Eye Wash was distributed nationwide to wholesale and retail facilities.

RECOMMENDATION: United Exchange Corp. is notifying its distributors and customers by recall letter and is arranging for return or disposal of all recalled products. Consumers and businesses that have product which is being recalled should stop using and selling them immediately.

Consumers with questions regarding this recall should contact the Customer Service Department at 800-814-8028, available Monday through Friday from 8:30 am to 5:30 pm (Pacific Time). Consumers can contact their physician or healthcare provider if they have additional questions about this product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• 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 alert, including a link to the press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm519602.htm

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You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

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