FDA recall D-0497-2017

United Exchange Corporation · Class II · drug

Product

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

Reason for recall

Lack of assurance of sterility

Distribution

Nationwide, Puerto Rico and Guyana

Key facts

Status: Terminated
Initiation date: 2016-09-02
Report date: 2017-03-08
Termination date: 2017-06-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cerritos, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0497-2017