Drug product
Clear Eyes Redness Relief (Handy Pocket Pal), Product Size: 0.2 FL. Oz., UPC#: 6-78112-15418-7
D-0489-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0489-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 16192, Exp 7/19; 16203, Exp 7/19; 16242, Exp 9/19; 16280, Exp 10/19; 16285, Exp 10/19; 16300, Exp 11/19; 16336, Exp 12/19; 17002, Exp 1/20; 17012, Exp 1/20; 17051, Exp 2/20; 17130, Exp 04/20; 17147, Exp 05/20
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility