EYE WASH 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 WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 4815…

Recall number

D-0499-2017

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 WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0904-6491-20