Drug product
Eye Irrigating Solution, 4 fl oz (118 mL) bottle, OTC, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0536-1083-97
D-0497-2017
Product summary
- Event
- Event 75092
- Status
- Terminated
- Classification
- Class II
- Quantity
- 112,320 bottles
- Official record key
drug-enforcement:D-0497-2017
Official wording
Reason: Lack of assurance of sterility
Code information: Lot # G15908, Exp 10/2018; G15909, Exp 01/2018; G16904, Exp 01/2019; G16908, Exp 02/2019; G16912, G16913, Exp 03/2019
Distribution pattern: Nationwide, Puerto Rico and Guyana
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility