Drug product
iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Tear Film Replenishment Mild Sterile, 0.5 FL OZ (15 mL), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-142-13
D-0434-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 4409 units
- Official record key
drug-enforcement:D-0434-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 17366, Exp 12/19
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility