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Recall Observatory FDA recall evidence

Drug product

Kroger 70% Isopropyl Alcohol First Aid Antiseptic 32 FL OZ (1 QT) 946 mL 5 Dist. By The Kroger Co., Cincinnati, Ohio 45202 NDC 30142-810-45, UPC 0 11110 37049

D-0799-2021

September 09, 2021

Class II

Product summary

Firm
Vi-Jon, Inc.
Event
Event 88653
Status
Terminated
Classification
Class II
Quantity
21,156 bottles
Official record key
drug-enforcement:D-0799-2021

Official wording

Reason: Labeling: Label Mix-Up.The recall has been initiated after receiving one complaint about incorrect labeling.The primary label on the front and back label on some of the bottles have 70% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces

Code information: Lot: 0542077 Exp. 07/2023

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix-Up