Reported Jan 23, 2013 · Terminated
I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031
James G. Cole, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: James G. Cole, Inc. · 1020 Wasco St Ste D and K · Hood River, OR · 97031
Is this the product you have?
- I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031
- Lot codes and dates
- N/A
- Amount recalled
- 253 bottles
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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