I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031

FDA recall notice · announced January 23, 2013 · James G. Cole

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Product was distributed nationwide and Canada
Lot/code information: N/A
Quantity: 253 bottles
Status: Terminated
Products in this recall event:
- I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031 (D-129-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.