Drug & medication recalls Moderate risk

Eye Irrigating Solution recalled over sterility concerns

Recall date
September 2, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
United Exchange Corporation recalls Eye Irrigating Solution, 4 fl oz (118 mL) bottle, OTC, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livo…
Recall number
D-0497-2017
FDA classification
Class II
Brand / firm
United Exchange Corporation
Sold / distributed
Nationwide, Puerto Rico and Guyana

Why it was recalled

Lack of assurance of sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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

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