D-0166-2023 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- January 25, 2023
- Initiation Date
- October 6, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 3,008 bottles; b) 120 bottles; c) 9,576 bottles
Product Description
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 Pattern
IA, NE
Code Information
Lots: 0001, 0005, 0007