FDA recall D-129-2013

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

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

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