I-C Drops recall: Sterility Concern
I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031
Why was I-C Drops recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
N/A
- Product
- I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031
- Recalling firm
- James G. Cole, Inc.
- Quantity
- 253 bottles
- Distribution
- Product was distributed nationwide and Canada
- Recall date
- January 23, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)