D-0499-2017 Class II Terminated

Recalled by United Exchange Corporation — Cerritos, CA

Recall Details

Product Type
Drugs
Report Date
March 8, 2017
Initiation Date
September 2, 2016
Termination Date
June 19, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
190,710 bottles

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

Distribution Pattern

Nationwide, Puerto Rico and Guyana

Code Information

Lot # G15906, Exp 10/2018; G15910, G15911, G15912, Exp 11/2018; G16901, G16902, G16903, Exp 01/2019; G16905, G16906, G16907, Exp 02/2019; G16910, G16911, Exp 03/2019