D-0384-2024 Class II Ongoing
FDA drug recall D-0384-2024 was initiated by Optikem International, Inc. on February 29, 2024 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 46,621 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 20, 2024
- Initiation Date
- February 29, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46,621 bottles
Product Description
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
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Product distributed Nationwide in the USA
Code Information
All lots within Expiry