Drug product
OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Ophthalmic Ointment, 0.5 fl oz. (15mL), Distributed by OCuSOFT, Inc. Rosenberg, TX 77471 USA
D-0453-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 13626 units
- Official record key
drug-enforcement:D-0453-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 18008 1/20 19105 4/22
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility