Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
I-C Drops Recalled by James G. Cole, Inc. Due to Lack of Assurance of Sterility: The product is...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact James G. Cole, Inc. directly.
Affected Products
I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031
Quantity: 253 bottles
Why Was This Recalled?
Lack of Assurance of Sterility: The product is being recalled because the product label does not state sterile in accordance with 21 CFR Part 200.50(a)(1), Ophthalmic Preparations and Dispensers, and it is not in compliance with 21 CFR Part 349, Ophthalmic Drug Products for Over-The-Counter Use.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About James G. Cole, Inc.
James G. Cole, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report