Drug product
iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Preservative Free, Product Size: 0.6 mL x 32 ct, Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-147-56
D-0431-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 48,973 units
- Official record key
drug-enforcement:D-0431-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: RGK 7/19 SDA 4/20 SFH 6/20 TAN 1/21
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility