James G. Cole Recalls I-C Drops Eye Cleansing Agent for Sterility Labeling
James G. Cole, Inc. is recalling I-C Drops Eye Cleansing Agent because the label does not state the product is sterile, as required by FDA regulations.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling compliance issue regarding sterility assurance without reported injuries or illnesses, fitting the Moderate severity criteria for minor labeling errors or low-risk contamination.
Plain-English summary
James G. Cole, Inc. is recalling 253 bottles of I-C Drops, Eye Cleansing Agent, 15 ml. The product was distributed nationwide and in Canada.
The recall is due to a lack of assurance of sterility. The product label does not state "sterile" in accordance with 21 CFR Part 200.50(a)(1) and is not in compliance with 21 CFR Part 349 for ophthalmic drug products for over-the-counter use.
Consumers should stop using the product and contact the recalling firm for instructions.
The recalled product
- Product
- I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031
- Manufacturer
- James G. Cole, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 253
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)
- N/A
Distribution
Distributed nationwide across the United States.
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