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.
- 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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