Status
Ongoing
Drug Enforcement D-0166-2023
CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.
Classification
Class II
Report Date
January 25, 2023
Termination Date
—
Product Information
- 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.
- Product quantity
- a) 3,008 bottles; b) 120 bottles; c) 9,576 bottles
- Reason for recall
- CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- IA, NE
Location & Firm
- Recalling firm
- Southwest Iowa Renewable Energy LLC
- Address
-
10868 189th St, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0166-2023
- Event ID
- 90953
- Recall initiation date
- October 6, 2022
- Center classification date
- January 19, 2023
- Code info
- Lots: 0001, 0005, 0007
- More code info
- —