drugs Class II Updated 2013-01-23

James G. Cole, Inc. recalls I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1

Recalled Product

I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: N/A
View official government recall

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