RecallDepth
Class II Ongoing

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.

Company
Southwest Iowa Renewable Energy Llc
Recall Initiated
October 6, 2022
Posted
January 25, 2023
Recall Number
D-0166-2023
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
a) 3,008 bottles; b) 120 bottles; c) 9,576 bottles
Firm Location
Council Bluffs, IA, United States

Reason for Recall

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

Distribution

IA, NE

Lot / Code Info

Lots: 0001, 0005, 0007

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