Drug product
OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Opthalmic Ointment, Net. wt. 1/8 oz (3.5 g), Sterile, Distributed by OCuSOFT, Inc. Rosenberg, TX 77471 USA
D-0452-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 19632 units
- Official record key
drug-enforcement:D-0452-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: SAP 1/20 SFI 6/20 TCI 3/21
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility