FDA-Drug2013-01-23Class II
I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031
James G. Cole, Inc.
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.
Sold states
Product was distributed nationwide and Canada
Affected count
253 bottles
Manufactured in
1020 Wasco St Ste D and K, N/A, Hood River, OR, United States
Products
I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-129-2013Don't want to check this manually?
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