I-C Drops Eye Cleansing Agent (James G. Cole) – Sterility issue (2012)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031
Brand
James G. Cole, Inc.
Lot Codes / Batch Numbers
N/A
Products Sold
N/A
James G. Cole, Inc. is recalling I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031 due to 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. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026