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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89706

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
March 02, 2022
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Vi-Jon, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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
Recall number
D-0644-2022
Initiated
March 02, 2022
Classification
Class II
Status
Terminated
Recalling firm
Vi-Jon, Inc.
Quantity
11,580 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Label Mix-Up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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