FDAFDA · Food and drugs·Recall number D-129-2013
I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031
Published January 23, 2013 · Recall initiated: August 28, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- James G. Cole, Inc.
- Distributor
- Product was distributed nationwide and Canada
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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