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Class II: temporary or reversible health riskTerminated

James G. Cole I-C Drops Recall

I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P

James G. Cole, Inc. · Hood River, OR

Risk level
Class II
Reported by FDA
Jan 23, 2013
Recall ID
D-129-2013
Check your lot numberHow we source this data

Summary

James G. Cole recalled I-C Drops starting Aug 28, 2012. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-129-2013 on Jan 23, 2013. Reason: 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. Status: Terminated.

Why it was 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.

Product description

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

Lot numbers, UPCs & expiration codes

N/A

Where it was sold

Product was distributed nationwide and Canada

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-129-2013
Classification
Class II
Status
Terminated
Recall initiated
Aug 28, 2012
FDA report date
Jan 23, 2013
Quantity
253 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
James G. Cole, Inc.

Original FDA data

Every field from FDA enforcement report D-129-2013, exactly as published.

Show all FDA fields
City
Hood River
State
OR
Status
Terminated
Country
United States
Event ID
62237
Address
1020 Wasco St Ste D and K
Postal code
97031
Report date
Jan 23, 2013
Product type
Drugs
Recall number
D-129-2013
Classification
Class II
Recalling firm
James G. Cole, Inc.
Product quantity
253 bottles
Termination date
Mar 12, 2013
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.
Voluntary / mandated
Voluntary: Firm initiated
Product description
I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031
Distribution pattern
Product was distributed nationwide and Canada
Recall initiation date
Aug 28, 2012
Initial firm notification
E-Mail
Center classification date
Jan 16, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-129-2013, published Jan 23, 2013. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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