SIREtizer Hand Sanitizer 80% recalled over manufacturing violations

Recall date

October 6, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Southwest Iowa Renewable Energy LLC recalls SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL), b) 10 oz (295 ml), UPC 8 60003 85882 0,…

Recall number

D-0166-2023

FDA classification

Class II

Brand / firm

Southwest Iowa Renewable Energy LLC

Sold / distributed

IA, NE

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.