Why it was recalled
Lack of Assurance of Sterility
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
Lot numbers, UPCs & expiration codes
All lots within Expiry
Where it was sold
Product distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0384-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 29, 2024
- FDA report date
- Mar 20, 2024
- Quantity
- 46,621 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Optikem International, Inc.
Original FDA data
Every field from FDA enforcement report D-0384-2024, exactly as published.
Show all FDA fields
- City
- Denver
- State
- CO
- Status
- Ongoing
- Country
- United States
- Event ID
- 94145
- Address
- 2172 S Jason St
- Code information
- All lots within Expiry
- Postal code
- 80223-4005
- Report date
- Mar 20, 2024
- Product type
- Drugs
- Recall number
- D-0384-2024
- Classification
- Class II
- Recalling firm
- Optikem International, Inc.
- Product quantity
- 46,621 bottles
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product distributed Nationwide in the USA
- Recall initiation date
- Feb 29, 2024
- Initial firm notification
- Letter
- Center classification date
- Mar 12, 2024