hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Plat
Summary
The FDA issued a Class II for hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle by Optikem International, Inc.. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0384-2024
Action Date
2024-03-20
Status
Ongoing
Category
drug
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/Code Info: All lots within Expiry
Quantity Affected: 46,621 bottles
Reason for Recall
Lack of Assurance of Sterility
Distribution
Product distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-29
Company
Denver, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 46 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Optikem International, Inc. has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Optikem International, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Optikem International, Inc. have FDA actions?
Optikem International, Inc. has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0384-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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