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Recall Observatory FDA recall evidence

Drug product

HEB 50% Isopropyl Alcohol First Aid Antiseptic, packaged in 16 FL OZ 91 PT) 473 mL brown bottles with brown colored closures. Distributed by HEB San Antonio, TX 78204. UPC 0 41220 25111 7

D-0644-2022

March 02, 2022

Class II

Product summary

Firm
Vi-Jon, Inc.
Event
Event 89706
Status
Terminated
Classification
Class II
Quantity
11,580 bottles
Official record key
drug-enforcement:D-0644-2022

Official wording

Reason: Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% 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. The back label is correct. Product is packaged in dark bottles.

Code information: Lot: 0546089 Exp. 09/2023

Distribution pattern: Product was distributed to one distributor in Texas for further distribution

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix-Up