D-129-2013 Class II Terminated
FDA drug recall D-129-2013 was initiated by James G. Cole, Inc. on August 28, 2012 and is designated Class II. Reason for recall: 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 … The recall status is terminated (terminated March 12, 2013). Affected quantity: 253 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 23, 2013
- Initiation Date
- August 28, 2012
- Termination Date
- March 12, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 253 bottles
Product Description
I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031
Reason for Recall
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.
Distribution Pattern
Product was distributed nationwide and Canada
Code Information
N/A