Southwest Iowa Renewable Energy LLC: Drug Recall
Recall #D-0166-2023 · 10/06/2022
Class II: Risk
Recall Details
- Recall Number
- D-0166-2023
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Southwest Iowa Renewable Energy LLC
- Status
- Ongoing
- Date Initiated
- 10/06/2022
- Location
- Council Bluffs, IA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- 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.
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.
Distribution Pattern
IA, NE
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.