Drug product
Eye Wash, 4 fl oz (118 mL) bottle, OTC, Distributed by: United Exchange Corp., 17211 Valley View Ave., Cerritos, CA 90703, Made in Korea, UPC Code: 780707005828
D-0498-2017
Product summary
- Event
- Event 75092
- Status
- Terminated
- Classification
- Class II
- Quantity
- 77,184 bottles
- Official record key
drug-enforcement:D-0498-2017
Official wording
Reason: Lack of assurance of sterility
Code information: Lot # G15901, G15902, G15903, G15904, Exp 07/31/2018; G16909, Exp 05/30/2019
Distribution pattern: Nationwide, Puerto Rico and Guyana
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility