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Recall Observatory FDA recall evidence

Drug product

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

D-129-2013

August 28, 2012

Class II

Product summary

Firm
James G. Cole, Inc.
Event
Event 62237
Status
Terminated
Classification
Class II
Quantity
253 bottles
Official record key
drug-enforcement:D-129-2013

Official wording

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.

Code information: N/A

Distribution pattern: Product was distributed nationwide and Canada

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    label does not state
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility