PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 8, 2017 Initiated: September 2, 2016 #D-0499-2017

Product Description

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

Reason for Recall

Lack of assurance of sterility

Details

Units Affected
190,710 bottles
Distribution
Nationwide, Puerto Rico and Guyana
Location
Cerritos, CA

Frequently Asked Questions

What product 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. Recalled by United Exchange Corporation. Units affected: 190,710 bottles.
Why was this product recalled?
Lack of assurance of sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on March 8, 2017. Severity: Moderate. Recall number: D-0499-2017.