Drug product
Ocusoft Tears Again Lubricant Eye Drops, 15 mL, Manufactured for: Ocusoft, Inc., Richmond, TX 77406-0429, NDC 54799-904-15
D-0398-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 139572 units
- Official record key
drug-enforcement:D-0398-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: 16250 09/19 16268 10/19 16301 11/19 17088 3/20 17109 4/20 17318 10/20 17323 10/20 18014 1/21 18045 2/21 18059 3/21 18063 3/21 18117 5/21 18134 5/21
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility