Drug product
Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, Twin Pack 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 59390-144-51
D-0479-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 2870 units
- Official record key
drug-enforcement:D-0479-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 17367, Exp 12/19; 18174, Exp 7/20
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility