Drug product
OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic, 5 mL, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 Made in USA, NDC 54799-505-05
D-0446-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 105609 units
- Official record key
drug-enforcement:D-0446-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: 17232 8/19 17334 11/19 18249 10/20 19125 4/21
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility