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-0496-2017
Product summary
- Event
- Event 75092
- Status
- Terminated
- Classification
- Class I
- Quantity
- 46,080 bottles
- Official record key
drug-enforcement:D-0496-2017
Official wording
Reason: Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
Code information: Lot # G15905, G15907, Exp 10/2018
Distribution pattern: Nationwide, Puerto Rico and Guyana
Derived failure modes
-
Unknown
Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.