Drug product
OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactured for OCuSOFT Inc. Rosenberg, TX 77471 USA, NDC 54799-904-15
D-0450-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 81217 units
- Official record key
drug-enforcement:D-0450-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: 17209 7/21 18168 7/22 18217 8/22 18260 10/22 19094 4/23
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility