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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90953

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

Open FDA event record

Event summary

Timeline bucket
October 06, 2022
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Southwest Iowa Renewable Energy LLC

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

SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL), b) 10 oz (295 ml), UPC 8 60003 85882 0, and c) 16.9 oz (500 ml), UPC 8 60003 85880 6 bottles, Southwest Iowa Renewable Energy, 10868 189th Street, Council Bluffs, IA 51503; Bottled by Southwest 6th Beverages, LLC, Lincoln, NE 68522 and Bottled by South Tenth Development, LLC, Lincoln, NE 68522.

D-0166-2023
Recall number
D-0166-2023
Initiated
October 06, 2022
Classification
Class II
Status
Ongoing
Quantity
a) 3,008 bottles; b) 120 bottles; c) 9,576 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations
Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.

Code information

Lots: 0001, 0005, 0007

Distribution pattern

IA, NE