Exact FDA event identifier

Event 86428

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

Open FDA event record

Event summary

Timeline bucket: August 14, 2020
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Volu-Sol, 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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

Volu-Sol Handrub Sanitizing Solution (Ethyl Alcohol, 69% v/v and Isopropyl Alcohol, 7.2% v/v) Topical Solution, 473 mL/ 16 fl oz bottle, Vou-Sol 5095 W 2100 S, Salt Lake City, UT 84120, NDC 74401-800-16

D-0033-2021

Recall number: D-0033-2021
Initiated: August 14, 2020
Classification: Class I
Status: Terminated
Recalling firm: Volu-Sol, Inc.
Quantity: N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.

Code information

Lot #: WHO100, WHO101, Exp. Date 4/2022; WHO104, WHO105, WHO108, WHO109, Exp. Date 05/2022

Distribution pattern

Sold to one distributor located in CA and one hospital system located in UT.