Drug product
Ocusoft Goniosoft Hypromellose 2.5% Opthalmic Demulcent Solution, 15 mL, Manufactured for: Ocusoft, Inc., Richmond, TX 77406-0429, NDC 54799-503-15
D-0397-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0397-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: 16260 9/19 17303 10/20 18032 2/21 18235 9/21 18285 11/21 19021 1/22
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility