Food recalls
Drug recalls
Topics
This week
Subscribe
Home
Companies
James G. Cole recalls
FDA enforcement reports naming James G. Cole, Inc. as the recalling firm.
Recall reports
1
Class I (serious)
0
Most recent report
Jan 23, 2013
All
1
Food
0
Drugs
1
Severity
All classes
Class I: serious
Class II: moderate
Class III: low
Date
Product
Reason
Class
Jan 23, 2013
I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P
Drug · James G. Cole, Inc.
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 compli…
Class II