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
D-0499-2017
Product summary
- Event
- Event 75092
- Status
- Terminated
- Classification
- Class II
- Quantity
- 190,710 bottles
- Official record key
drug-enforcement:D-0499-2017
Official wording
Reason: Lack of assurance of sterility
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
Distribution pattern: Nationwide, Puerto Rico and Guyana
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility