Drug Enforcement D-0384-2024

Lack of Assurance of Sterility

Status

Ongoing

Classification

Class II

Report Date

March 20, 2024

Termination Date

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Product Information

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
Product quantity
46,621 bottles
Reason for recall
Lack of Assurance of Sterility
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Product distributed Nationwide in the USA

Location & Firm

Recalling firm
Optikem International, Inc.
Address
2172 S Jason St, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0384-2024
Event ID
94145
Recall initiation date
February 29, 2024
Center classification date
March 12, 2024
Code info
All lots within Expiry
More code info
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