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.
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.
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send James G. Cole, Inc. to request your refund or repair — edit it as you like.
Subject: Recall D-129-2013 — James G. Cole, Inc. James G. Cole, Inc. recalls I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Hello, I own a James G. Cole, Inc. recalls I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031 that is covered by recall D-129-2013 from James G. Cole, Inc.. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
