Drug product
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.
D-0166-2023
Product summary
- Event
- Event 90953
- Status
- Ongoing
- Classification
- Class II
- Quantity
- a) 3,008 bottles; b) 120 bottles; c) 9,576 bottles
- Official record key
drug-enforcement:D-0166-2023
Official wording
Reason: CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.
Code information: Lots: 0001, 0005, 0007
Distribution pattern: IA, NE
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Potency or specification failure
Superpotent