FDA recall D-0384-2024

Optikem International, Inc. · Class II · 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

Reason for recall

Lack of Assurance of Sterility

Distribution

Product distributed Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2024-02-29
Report date: 2024-03-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Denver, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0384-2024