FDA Recalls HylaTears Lubricant Eye Drops for Sterility Assurance Issue
Optikem International is recalling 46,621 bottles of hyalogic For Dry Eyes, HylaTears Lubricant Eye Drops due to lack of assurance of sterility. The product is distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of eye drops where sterility cannot be assured. Eye drops applied directly to the eye present a risk of serious infection or complications. No illnesses or injuries have been reported in the source, placing this in the rubric category of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Optikem International, Inc. is recalling hyalogic For Dry Eyes, HylaTears Lubricant Eye Drops (0.67 FL OZ/20mL bottles) due to lack of assurance of sterility. This means the manufacturer cannot confirm the product meets sterility requirements required for eye drops.
The affected product was distributed nationwide in the United States. The recall includes 46,621 bottles, and all affected lots are within their expiration dates.
Consumers who have purchased this product should stop using it immediately. Eye drops must be sterile to prevent eye infections and other serious complications. Anyone who has experienced eye irritation, redness, discharge, or other concerns after using this product should consult a healthcare provider. For more information, contact the manufacturer or the FDA.
The recalled product
- 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
- Manufacturer
- Optikem International, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- sterility-defect
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within Expiry
Distribution
Distributed nationwide across the United States.
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