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

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

Class I — High risk. Reasonable probability of serious harm or death.

Why it was recalled

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

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

Recalling firm
United Exchange Corporation
NDC code
0904-6491-20
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0496-2017

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.