# FDA recall D-0166-2023

> **Southwest Iowa Renewable Energy LLC** · Class II · drug recall initiated 2022-10-06.

## Product

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.

## Reason for recall

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

## Distribution

IA, NE

## Key facts

- **Recall number:** D-0166-2023
- **Recalling firm:** Southwest Iowa Renewable Energy LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2022-10-06
- **Report date:** 2023-01-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Council Bluffs, IA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0166-2023

## Citation

> AI Analytics. FDA recall D-0166-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0166-2023. Source: US FDA. Licensed CC0.

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