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-0496-2017

FDA classification

Class I

Brand / firm

United Exchange Corporation

Sold / distributed

Nationwide, Puerto Rico and Guyana

Why it was recalled

Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

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