US Drug Recall Register
Class II · Moderate risk Terminated Initiated Sep 2, 2016 (10 years ago)

Eye Irrigating Solution

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of assurance of sterility

What was recalled

Eye Irrigating Solution, 4 fl oz (118 mL) bottle, OTC, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0536-1083-97

Recalling firm
United Exchange Corporation
NDC code
0536-1083-97
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0497-2017

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.