Recalls / Class II

Class IID-0384-2024

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

Affected lot / code info

All lots within Expiry

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm

Optikem International, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

2172 S Jason St, N/A, Denver, Colorado 80223-4005

Distribution

Quantity

46,621 bottles

Distribution pattern

Product distributed Nationwide in the USA

Timeline

Recall initiated

2024-02-29

FDA classified

2024-03-12

Posted by FDA

2024-03-20

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0384-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.