← FDA ENFORCEMENT
D-0384-2024Class II

Optikem International, Inc.

Recalling firm
Optikem International, Inc.
Product type
Drug
Status
Ongoing
Report date
2024-03-20
Distribution
Product distributed Nationwide in the USA
Firm state
CO
Product quantity
46,621 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

Code / lot info

All lots within Expiry

Other recalls SPEQ maps to Environmental Monitoring
2026-07-22Class IArgon Medical Devices, Inc2026-07-22Class IIOlympus Corporation of the Americas2026-07-22Class IIChiesi USA, Inc.2026-07-22Class IICareFusion 213, LLC
See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.