FDA recall D-0499-2017
United Exchange Corporation · Class II · drug
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
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-0499-2017