Drug product
OCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-76
D-0481-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 19632 units
- Official record key
drug-enforcement:D-0481-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: SAP 1/20 3/16/2018 SFI 6/20 10/29/2018 TCI 3/21
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility