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.
This recall is currently active, issued January 25, 2023. It was issued by 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
- Official Source
- View on FDA website ↗
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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