Drug product
Tetcaine (Tetracaine Hydrochloride) Ophthalmic Solution USP, 0. 5 fl oz (15 mL), Rx only, Manufactured for OCuSOFT, Inc. Rosenberg, TX 77471 USA, NDC 54799-502-15
D-0441-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 88,008 units
- Official record key
drug-enforcement:D-0441-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: 17205 7/19 17206 7/19 18003 1/20 18097 4/20 18166 7/20 18292 11/20 19106 4/21
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility