FDAFDA · Food and drugs·Recall number D-0166-2023
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.
Published January 25, 2023 · Recall initiated: October 6, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Southwest Iowa Renewable Energy LLC
- Distributor
- IA, NE
- Lot
- Lots: 0001, 0005, 0007
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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