Drug product
hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Riverside, MO 64150
D-0384-2024
Product summary
- Event
- Event 94145
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 46,621 bottles
- Official record key
drug-enforcement:D-0384-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: All lots within Expiry
Distribution pattern: Product distributed Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility