I-C Drops — Class II drug recall D-129-2013
Terminated recall by James G. Cole, Inc., reported 2013-01-23, distributed nationwide. Lack of Assurance of Sterility: The product is being recalled because the product label does not state sterile
| Recall number | D-129-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | James G. Cole, Inc., Hood River, OR, United States |
| Recall initiated | 2012-08-28 |
| Classified | 2013-01-16 |
| Reported by FDA | 2013-01-23 |
| Terminated | 2013-03-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 253 bottles |
| Reason classes | labeling, sterility |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-129-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.