FDA Drug recall D-129-2013
I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031
- FDA Drug
- Class II
- terminated
- Published 2013-01-23
On 2013-01-23 the FDA classified a Class II recall of I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031 by James G Cole, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-129-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-28 |
| Published | 2013-01-23 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | James G Cole |
| Distribution | US |
Product
I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031
Reason
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.
Identifiers
| code_info | N/A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-129-2013%22
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