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U.S. Department of Health and Human Services

Enforcement Report - Week of January 23, 2013

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Event Detail

Event ID 62237
Product Type Drugs
Status Ongoing
Recalling Firm James G. Cole, Inc.
City Hood River
State OR
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-28
Initial Firm Notification of
Consignee or Public
Distribution Pattern Product was distributed nationwide and Canada

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031 N/A Class II 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. 253 bottles D-129-2013