# FDA recall D-129-2013

> **James G. Cole, Inc.** · Class II · drug recall initiated 2012-08-28.

## 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.

## Distribution

Product was distributed nationwide and Canada

## Key facts

- **Recall number:** D-129-2013
- **Recalling firm:** James G. Cole, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-08-28
- **Report date:** 2013-01-23
- **Termination date:** 2013-03-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hood River, OR, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-129-2013

## Citation

> AI Analytics. FDA recall D-129-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-129-2013. Source: US FDA. Licensed CC0.

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