Drug product
PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO
D-0621-2026
Product summary
- Firm
- PReye LLC
- Event
- Event 99032
- Status
- Ongoing
- Classification
- Class II
- Quantity
- approximate 50 to 60 bottles
- Official record key
drug-enforcement:D-0621-2026
Official wording
Reason: Lack of Assurance of Sterility
Code information: All lots within expiry
Distribution pattern: CO
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility