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Recall Observatory FDA recall evidence

Drug product

Topical Solution USP Hydrogen Peroxide First Aid Antiseptic Oral Debriding Agent 32 Fl. Oz. (1 QT) 946 mL bottle, Distributed By: Discount Drug Mart 211 Commerce Drive, Medina, Ohio 44256 NDC 53943-871-45 UPC 0-93351-12758-8

D-0520-2019

February 20, 2019

Class II

Product summary

Firm
Vi-Jon, Inc.
Event
Event 82215
Status
Terminated
Classification
Class II
Quantity
6756 32 oz bottles
Official record key
drug-enforcement:D-0520-2019

Official wording

Reason: Cross Contamination: Presence of IPA in finished product.

Code information: Lot: 0384244 Exp. 01/2020

Distribution pattern: Distributed in Ohio

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Cross Contamination: Presence of IPA in finished product.