Drug product
OCuSOFT Tears Again Sterile Lubricant Eye Drops, Net Wt 30mL (1 fl oz), Manufactured for OCuSOFT Inc., Rosenberg, TX 77471 USA, NDC 54799-904-30
D-0451-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 29326 units
- Official record key
drug-enforcement:D-0451-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: 17208 7/21 17209 7/21 19001 1/23
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility