FDA recall D-0496-2017

Product

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

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

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-0496-2017