FDA Recall D-0496-2017
United Exchange Corporation · Cerritos, CA
Class I — life-threatening Terminated 290 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0496-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- Nationwide, Puerto Rico and Guyana
- Recall initiated
- 2016-09-02
- Classified by FDA Center
- 2017-02-27
- FDA published
- 2017-03-08
- Terminated
- 2017-06-19
- Recalling firm
- United Exchange Corporation
- Firm location
- Cerritos, CA